Premature infant amniotic bath incubator

ABSTRACT

Devices, systems, and methods described herein can provide a simulated fluid environment similar to the mother&#39;s womb to recreate an ideal or more familiar environment for infants who are born before their ideal due date. In some embodiments, the premature infant amniotic bath incubator can comprise an incubating tank with synthetic or simulated amniotic fluid, a heating element(s), a temperature sensor(s), and/or thermostats) for temperature regulation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit under 35 U.S.C. §119(e) ofU.S. Provisional Application No. 62/252,060, filed Nov. 6, 2015, andentitled “PREMATURE INFANT AMNIOTIC BATH INCUBATOR.” The foregoingapplication is hereby incorporated herein by reference in its entiretyunder 37 C.F.R. §1.57.

BACKGROUND

The systems, devices, and methods disclosed herein relate to the care ofinfants, and particular prematurely born infants. Preterm birth affectsabout one of every nine infants born in the United States. This amountsto 400,000 infants each year in the US alone and nearly 15 millionglobally. Preterm birth is a leading contributor to infant death and theleading cause of long-term neurological disabilities in children. Ofthose born preterm, 75,464 babies were very preterm, or born before 32weeks, contributing to the largest number of infant deaths. Theseinfants on average had a length of stay of 46.2 days in the neonatalintensive care unit (NICU).

Care of premature infants generally involves careful control of theenvironment surrounding the infant. Due to heightened risks of healthcomplications, maintaining body temperature and sterility is of primaryimportance. Infants in general and preterm infants in particular haverelatively large surface area to mass ratios, making them extremelyvulnerable to heat loss. They also exhibit thin and poor thermalinsulation compared to adults and a small amount of mass to act as aheatsink.

Current methods of care generally include swaddling the infant in warmclothing and providing heating apparatuses. While these apparatuses mayadequately warm an infant to some degree, they fail to address issues ofdermal desiccation even when humidified air is provided. They may alsoresult in difficulty of movement due to the infant's removal from afluid environment. Further, difficulties associated with administeringmedications may arise as well.

There is therefore a need for a premature infant incubator that allowsmovement and exercise of infant arms and legs within a fluidenvironment, improves thermal regulation of the infant, and surroundsthe infant in a fluid environment. There is also a need for anincubation method that provides transdermal hydration of the infant andtransdermal topical nutrition and pharmaceutical treatment for theinfant through addition of nutritional and/or pharmaceutical content tothe simulated amniotic fluid.

SUMMARY

As such, in some embodiments, the devices, systems, and methodsdescribed herein are directed to an infant amniotic bath incubator toaddress the shortcomings of existing technologies. In some embodiments,a premature infant amniotic bath incubator can comprise an incubatingtank with a volume of synthetic or simulated amniotic fluid, a heatingelement(s), a temperature sensor(s), and/or thermostat(s) fortemperature regulation. In certain embodiments, the premature infantamniotic bath incubator can further comprise an inflow channel foradding synthetic or simulated amniotic fluid and/or an outflow drainagechannel for removing waste fluid from the bath.

In some embodiments, a neonatal incubator comprises: an amniotic bathcomprising synthetic amniotic fluid, wherein the synthetic amnioticfluid comprises one or more electrolytes and one or more minerals,wherein the synthetic amniotic fluid is produced by: installing acartridge in the neonatal incubator, wherein the cartridge comprises theone or more electrolytes and the one or more minerals; and dissolvingcontents of the cartridge in purified water; a purified water supplytank configured to provide the purified water for dissolving contents ofthe cartridge; a waste water removal tank configured to remove wastewater from the amniotic bath; and a bath cover selectively attachable tothe amniotic bath, wherein the bath cover is sterile and disposable, andwherein the bath cover comprises a safety harness configured to maintaina position of the infant inside the amniotic bath such that a head ofthe infant is not submerged in the amniotic bath.

In certain embodiments, the neonatal incubator can further comprise atemperature sensor configured to detect a temperature of the syntheticamniotic fluid; and a heater configured to heat the synthetic amnioticfluid when the detected temperature is below a predetermined thresholdvalue. In some embodiments, the purified water supply tank isselectively removable from the neonatal incubator. In certainembodiments, the waste water removal tank is selectively removable fromthe neonatal incubator. In some embodiments, the waste water removaltank can comprise one or more rechargeable batteries and/or one or morepumps.

In certain embodiments, the synthetic amniotic fluid further comprisesalbumin. In some embodiments, the cartridge further comprises albumin.In certain embodiments, the synthetic amniotic fluid further comprisesglucose and one or more amino acids, wherein the glucose and the one ormore amino acids are dissolved in the synthetic amniotic fluid bydissolving contents of a second cartridge, wherein the second cartridgecomprises the glucose and the one or more amino acids. In someembodiments, the cartridge can further comprise glucose and/or the oneor more amino acids, which can be dissolved in the synthetic amnioticfluid together with other components, such as electrolytes and/orminerals. In some embodiments, the synthetic amniotic fluid furthercomprises one or more medicines configured to be absorbed by the infant,wherein the one or more medicines are dissolved in the syntheticamniotic fluid by dissolving contents of a second cartridge, wherein thesecond cartridge comprises the one or more medicines. In someembodiments, the same cartridge can further comprise the one or moremedicines, which can be dissolved in the synthetic amniotic fluidtogether with other components, such as electrolytes and/or minerals. Incertain embodiments, the synthetic amniotic fluid comprises a pH levelbetween a range of about 7.5 and about 9.0. In some embodiments, a pHlevel and osmolality of the synthetic amniotic fluid is modifiedaccording to growth of the infant.

In certain embodiments, the neonatal incubator further comprises asynthetic amniotic fluid disposal unit configured to facilitate disposalof stool and the synthetic amniotic fluid to the waste water tank,wherein the synthetic amniotic fluid disposal unit further comprises astool collector, a bath fluid inflow portion, one or more filters, and aplug unit. In certain embodiments, the neonatal incubator furthercomprises an adapter seat configured to be coupled to the bath cover,wherein the adapter seat comprises the adapter seat is selected from aplurality of adapter seats, wherein each of the plurality of adapterseats comprises different sizes. In some embodiments, the syntheticamniotic fluid is provided to the bath through a divergent nozzle.

In some embodiments, the neonatal incubator further comprises a fluidsensor configured to be worn around a neck or face of the infant,wherein the fluid sensor is configured to detect presence of fluid incontact with the fluid sensor, wherein detection of presence of fluid incontact with the fluid sensor causes at least a portion of the syntheticamniotic fluid to be automatically removed from the amniotic baththrough the waste water removal system. In certain embodiments, theneonatal incubator further comprises an alarm, wherein detection ofpresence of fluid in contact with the fluid sensor further causes toautomatically trigger the alarm. In some embodiments, oxygenation can beprovided to the infant through the umbilical cord and/or throughextracorporal membrane oxygenation (ECMO) and/or an endotracheal tubedeemed safe for submersion. In such embodiments, the infant face andneck can also be submerged in the synthetic amniotic fluid.

In some embodiments, the neonatal incubator further comprises one ormore bridges placed over the bath cover. In certain embodiments, the oneor bridges are configured to anchor a first end of one or more of afeeding tube, an oxygen tube, cardiac lead wiring, pulse oximeterwiring, and an umbilical cord or catheter over the synthetic amnioticfluid. In some embodiments, a second end of one or more of the feedingtube, the oxygen tube, and the umbilical catheter is connected to theinfant.

In certain embodiments, a neonatal incubator for an infant comprises: anamniotic bath comprising synthetic amniotic fluid, wherein the syntheticamniotic fluid comprises one or more electrolytes and one or moreminerals, and in some embodiments one or more amino acids, glucose,proteins, and/or pharmaceuticals or other therapeutic agents, whereinthe synthetic amniotic fluid is produced by: installing a cartridge inthe neonatal incubator, wherein the cartridge comprises the one or moreelectrolytes and the one or more minerals, and in some embodiments oneor more amino acids, glucose, proteins, and/or pharmaceuticals; anddissolving contents of the cartridge in purified water; a purified watersupply tank configured to provide the purified water for dissolvingcontents of the cartridge, for example through use of an internal orexternal water purification system such as reverse osmosis and/ordeionizing exchanger with or without a micro filter or a UV lightfilter; a waste water removal tank configured to remove waste water fromthe amniotic bath; and a bath cover selectively attachable to theamniotic bath, wherein the bath cover is sterile and disposable, whereinthe bath cover comprises a safety harness configured to maintain aposition of the infant inside the amniotic bath such that a head of theinfant is not submerged in the amniotic bath, and wherein two peripheralsides of the bath cover are connected by a bridge over the bath, whereinthe bridge comprises an anchoring mechanism for anchoring one end of anumbilical cord or one or more catheters, tubes, lines, and/or wiringover the synthetic amniotic fluid. In certain embodiments, the bridgecan only be anchored to one side of the bath and its position can beadjusted over the infant through a swiveling mechanism of the anchor tothe disposable cover.

In some embodiments, the neonatal incubator further comprises a fluidsensor configured to be worn around a neck or face of the infant,wherein the fluid sensor is configured to detect presence of fluid incontact with the fluid sensor, wherein detection of presence of fluid incontact with the fluid sensor causes at least a portion of the syntheticamniotic fluid to be automatically removed from the amniotic baththrough the waste water removal system, such as sufficient to preventfluid from entering the nasal or oropharyngeal passageways of theinfant. In certain embodiments, the bridge is configured to furtheranchor a first end of a feeding or other tube over the syntheticamniotic fluid. In some embodiments, a second end of the umbilicalcatheter is connected to the infant.

In certain embodiments, the synthetic amniotic fluid further comprisesone or more therapeutic agents, such as medicines configured to beabsorbed by the infant, wherein the one or more medicines are dissolvedin the synthetic amniotic fluid by dissolving contents of, a secondcartridge, wherein the second cartridge comprises the one or moremedicines. In another embodiment, one or more medicines can be added tothe same cartridge comprising electrolytes, minerals, amino acids,and/or glucose, in which contents of a single cartridge can be mixedwith purified water.

In some embodiments, a method of incubating an infant comprises:providing a neonatal incubator for the infant, wherein the neonatalincubator comprises an amniotic bath; providing purified water to theamniotic bath; dissolving contents of a cartridge in the purified waterto obtain a synthetic amniotic fluid, wherein the contents of thecartridge comprise one or more electrolytes and one or more minerals;placing a selectively attachable bath cover over the amniotic bath,wherein the bath cover is sterile and disposable; placing the infant inthe amniotic bath and attaching the infant to a safety harness of thebath cover, wherein the safety harness maintains a position of theinfant inside the amniotic bath such that a head of the infant is notsubmerged in the synthetic amniotic fluid; attaching a first end of anumbilical cord to a portion of the infant submerged in the syntheticamniotic fluid and attaching a second end of the umbilical cord to abridge over the bath, wherein the bridge is configured to connect one ortwo peripheral sides of the bath cover over the bath; and periodicallyadding synthetic amniotic fluid and/or removing waste water from theamniotic bath.

In some embodiments, the method further comprises detecting thetemperature of purified or unpurified fluid/water prior to mixing toobtain synthetic amniotic fluid and heating the purified or unpurifiedwater when the detected temperature is below a predetermined thresholdvalue, for example about 37° C. In certain embodiments, after thepreheated water is mixed with contents of the cartridge and added to theamniotic bath, the method further comprises: detecting a secondtemperature of the synthetic amniotic fluid; and heating the syntheticamniotic fluid when the detected temperature is below a predeterminedthreshold value. In some embodiments, the purified water is provided tothe amniotic bath by removing a modular purified or unpurified watertank from the neonatal incubator, adding purified or unpurified water tothe modular purified or unpurified water tank, and reattaching themodular purified water tank to the neonatal incubator. In someembodiments, the neonatal incubator can comprise a built-in waterpurification system. In other embodiments, an external waterpurification system can be attached and/or used in conjunction with theneonatal incubator. In certain embodiments, the waste water is removedfrom the amniotic bath by collecting waste water from the amniotic bathin a modular waste water tank of the neonatal incubator, removing themodular waste water tank, emptying the waste water from the modularwaste water tank, and reattaching the modular waste water tank to theneonatal incubator.

In some embodiments, the method further comprises dissolving albumin inthe synthetic amniotic fluid. In certain embodiments, the method furthercomprises providing one or more nutrients to the infant by dissolvingcontents of a second cartridge in the purified water, wherein thecontents of the second cartridge comprise glucose and one or more aminoacids. In some embodiments, the cartridge can further comprise glucoseand/or the one or more amino acids, which can be dissolved in thesynthetic amniotic fluid together with other components, such aselectrolytes and/or minerals. In some embodiments, the method furthercomprises administering one or more medicines to the infant bydissolving contents of a second cartridge in the purified water, whereinthe contents of the second cartridge comprise the one or more medicines.In some embodiments, the same cartridge can further comprise the one ormore medicines, which can be dissolved in the synthetic amniotic fluidtogether with other components, such as electrolytes and/or minerals.

In certain embodiments, the method further comprises attaching anecklace around a neck of the infant, wherein the necklace comprises afluid sensor, wherein the fluid sensor is configured to detect presenceof fluid in contact with the fluid sensor. The sensor need notnecessarily be a necklace, but can be otherwise operably attached to thehead or neck, such as via an adhesive bandage for example. In someembodiments, the method further comprises automatically removing atleast a portion of the synthetic amniotic fluid from the amniotic bathwhen the fluid sensor detects presence of fluid in contact with thefluid sensor. In certain embodiments, the method further comprisesattaching a first end of a feeding tube to the infant and attaching asecond end of the feeding tube to the bridge.

For purposes of summarizing the invention and the advantages achievedover the prior art, certain objects and advantages are described herein.Of course, it is to be understood that not necessarily all such objectsor advantages need to be achieved in accordance with any particularembodiment. Thus, for example, those skilled in the art will recognizethat the invention may be embodied or carried out in a manner that canachieve or optimize one advantage or a group of advantages withoutnecessarily achieving other objects or advantages.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments will becomereadily apparent to those skilled in the art from the following detaileddescription having reference to the attached figures, the invention notbeing limited to any particular disclosed embodiment(s).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an infant placed inside anembodiment of an amniotic bath incubator.

FIG. 2 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants.

FIG. 3 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants with the dome removed.

FIG. 4 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants with a dome and cover removed.

FIG. 5 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants with a changing panel extended.

FIG. 6 illustrates a front perspective view of an embodiment of a freshfluid reservoir of an amniotic bath incubator for premature infants.

FIG. 7 illustrates a rear perspective view of an embodiment of a freshfluid reservoir of an amniotic bath incubator for premature infants.

FIG. 8 illustrates an exploded view of an embodiment of a fresh fluidreservoir and a synthetic amniotic fluid cartridge of an amniotic bathincubator for premature infants.

FIG. 9 illustrates a front perspective view of an embodiment of a wastefluid primary tank of an amniotic bath incubator for premature infants.

FIG. 10 illustrates a front perspective view of an embodiment of a wastefluid secondary tank of an amniotic bath incubator for prematureinfants.

FIG. 11 illustrates a section view of an embodiment of a bath portion, afirst tank, and a second tank of an amniotic bath incubator forpremature infants.

FIG. 11A illustrates a cross section view of an amniotic fluid disposalunit of an amniotic bath incubator.

FIG. 11B illustrates a perspective view of an adapter of an amnioticbath incubator.

FIG. 12 is a block diagram depicting an overview of an embodiment of anamniotic bath incubator system for premature infants.

FIG. 13 is a block diagram depicting an embodiment of a fluidpreparation sub-system of an amniotic bath incubator system forpremature infants.

FIG. 14 is a block diagram depicting an embodiment of a bath sub-systemof an amniotic bath incubator system for premature infants.

FIG. 15 is a block diagram depicting an embodiment of a wastewatersub-system of an amniotic bath incubator system for premature infants.

FIG. 16 is a block diagram depicting an embodiment of a water heatingsub-system of an amniotic bath incubator system for premature infants.

FIG. 17 is a block diagram depicting an embodiment of a water heatingsub-system of an amniotic bath incubator system for premature infants.

FIG. 18 is a block diagram depicting an embodiment of a water heatingsub-system of an amniotic bath incubator system for premature infants.

FIG. 18A is a block diagram depicting an embodiment of a water heatingsub-system of an amniotic bath incubator system for premature infants.

FIG. 19, 19A-B are block diagrams depicting an embodiment of a computerhardware system configured to run software for one or more embodimentsof the amniotic bath incubator systems, devices, and methods.

FIGS. 20A-B are block diagrams depicting one or more embodiments ofchanging and rinsing bath fluid of an amniotic bath incubator system forpremature infants.

FIG. 21 is a block diagram depicting one or more embodiments ofpreparing bath fluid of an amniotic bath incubator system for prematureinfants.

FIG. 22 is a block diagram depicting one or more embodiments ofpreparing bath fluid of an amniotic bath incubator system for prematureinfants.

FIG. 23 is a block diagram depicting one or more embodiments ofdisinfecting an amniotic bath incubator system for premature infants.

FIG. 24 is a block diagram depicting one or more embodiments ofreplacing a bath cover of an amniotic bath incubator system forpremature infants.

FIGS. 25A-B are block diagrams depicting one or more embodiments ofdischarging a wastewater tank of an amniotic bath incubator system forpremature infants.

FIGS. 26A-B are block diagrams depicting one or more embodiments ofreplacing and/or filling a fresh water tank of an amniotic bathincubator system for premature infants.

DETAILED DESCRIPTION

The devices, systems, and methods described herein relate in someaspects to neonatal incubators, and more specifically to amniotic bathincubators for mammals, such as infants including premature infants,preterm infants, and/or low birth weight term infants, includingveterinary applications. In some embodiments, the incubators could beutilized for non-neonates, such as, for example, hypothermic orotherwise ill children or adults in some cases. Some embodiments of thedevices, systems, and methods described herein can have severalsignificant benefits for such infants compared to the currently existingtechnologies of convection and radiant-based incubators. Not to belimited by theory, some of such benefits can include, for example, oneor more of the following: (1) improved thermoregulation, (2) improvedhydration through reconstitution of the in-utero intramembranous pathwayof fluid absorption, (3) provision of a fluid environment for exerciseand movement of appendages of the infant, and (4) providing of a morenatural environment for skin development. Some advantages of thedevices, systems, and methods described herein are discussed in moredetail below.

Improved Thermal Regulation

Immediately upon birth, fetal reliance on the maternal heat reservoirceases and a wet infant is born into a relatively cold and hostileenvironment. Preterm infants, among others, have several significantdisadvantages compared to term infants for heat regulation and improvedthermoregulation is a significant challenge in NICUs. Preterm infantshave little insulating subcutaneous fat compared to term infants makingthem far more susceptible to heat loss. In addition, preterm infantshave very thin skin leading to significant transepidermal water loss andevaporative heat loss. The thin keratinized layer can be completelyabsent in infants until the 26th week making their skin permeable towater. Evaporative heat exchange can reach 50 W/m² in preterm infantscompared to 5 W/m² in term infants. In infants born very prematurely,such as at 25-27 weeks, evaporative heat loss can be, in some cases, themost important mode of heat loss for more than 10 days after birth. Inaddition, preterm infants can have blood vessels close to skin, leadingto an increased rate of heat loss.

In addition, preterm infants can have excessive amounts of evaporativeheat loss due to a greater surface area to volume ratio which comparedto adults can be up to three times the ratio for infants of 1500 g andup to six times the ratio for extreme preterm infants of 500 g. Becauseof the lack of significant insulating subcutaneous fat, heat can be moreeasily lost from internal organs to skin leading to more rapid decreasein internal temperature. Overall, the rate of heat loss in newbornsimmediately after birth can be estimated at 33 to 47 kcal/kg/min andpreterm infants are at the highest risk for heat loss.

In addition to their increased risk for heat loss, preterm infants canalso have very poor mechanisms for body temperature regulation and canbe far more limited than term infants in generating heat. Preterminfants can lack the shivering mechanism used to maintain bodytemperature. In addition, a term infant's reaction to rapid temperaturefluctuations upon birth can include increased voluntary muscularactivity which can be mostly absent in very preterm infants. Brown fatused for non-shivering thermogenesis can be significantly more limitedin preterm infants, and thus more calories intended for natural growthare diverted to heat generation.

Thus protecting infants from heat loss and providing appropriatethermoregulation can be one of the most important goals in the NICU.Improved thermoregulation can increase preterm infants' chances ofsurvival, reduce infants' need to perform heat producing metabolic workusing energy intended for growth and development, and eliminate problemsand complications associated with rewarming of cold infants.

In intrauterine life, a fetus can be thermoregulated within the amnioticfluid with a fetal temperature of approximately 0.5° C. higher than thematernal temperature due to the natural fetal heat production. Howeverupon premature birth, a preterm infant can be exposed to air in thenursery which can be very cold compared to the environment previouslyexperienced in-utero. In addition, skin can be initially covered withamniotic fluid causing rapid heat loss due to evaporation. This can befollowed by thermogenic responses by the infant to increase basal heatproduction.

Temperature loss in a preterm infant can be related to the temperatureand humidity of the environment air (delivery room/NICU), the flowvelocity of surrounding air from nursing and examination, temperature ofsurfaces facing the infant (incubator walls/bedding material), and thetemperature of surfaces in contact with the infant.

Not to be limited by theory, thermal response in infants prematurelyexposed to a cold nursery environment is generally mediated primarilythrough the sympathetic nervous system and release of norepinepherine.Preterm infants often lack the shivering mechanism of term infants. Theearliest response to the sympathetic nervous system can bevasoconstriction in deep dermal layers, thus reducing blood flow to theskin creating insulation between the core and the environment. However,the reduced subcutaneous fat in preterm infants can diminish thiseffective insulating property. Glycolysis (breakdown of sugar)stimulated from epinephrine release can also be a source of heatgeneration for preterm infants. This response can not only havedeleterious effects in breakdown of calories otherwise intended forgrowth, but also may result in periods of transient hyperglycemias.Brown fat can provide a source of non-shivering thermogenesis innewborns. Abundance of mitochondria in these cells can break downtriglycerides into metabolic acids producing heat and increasingmetabolic activity by two to three folds. However, preterm infants canhave little to no brown fat and may not be capable of any more than a25% increase in metabolic rate despite the most severe cold stress.Control of voluntary muscle tone, flexion, posture, and increased motoractivity may serve to augment heat production in skeletal muscle, butthis mechanism can be limited in preterm infants because ofunderdeveloped musculature. Overall, a preterm infant's thermoregulatoryreaction and maintenance of core temperature in response toextra-uterine exposure to cold environment can mainly be at the expenseof metabolically generated heat. In addition, an infant's reaction tocold stress can have significant repercussions for normal development,not only in terms of caloric loss which otherwise would be intended forgrowth and development but insults to normal development associated withinfant's response to cold stress such as periods of high epinephrinerelease and periods of transient hyperglycemia.

Studies have shown deleterious differences in preterm infants nurturedin dry, ambient air environments in minimally different temperatures of35° C. and 36.5° C. in the first week of life. Rectal temperatures wereshown to be the same, but significant difference in weight gain was seenwith warmer infants concluding that thermogenic response in slightlycooler infants was sufficient to consume considerable enough caloriesotherwise used for growth.

Current practice upon birth generally includes drying of the infant inthe delivery room to decrease evaporative heat loss and bundling orswaddling of infants to decrease exposure to cold air followed byplacing newborn on mother's arms and chest (kangaroo care). These steps,however, are inadequate in preterm infants. Preterm infants instead aregenerally placed initially on radiant warmers to allow examination andintervention by medical staff. Once the preterm infant is stable, theyare placed in a convectively warmed incubator enclosure with an airtemperature of 36-37° C. with variety of swaddling heat shields. Thereare significant shortcomings, however, in preterm infantthermoregulation.

Current convection warmed incubators generally comprise a plastic hoodover the infant with access ports or hand holes to minimize air flow.Abdominal skin surface temperature detectors can be used to regulateincubator heating in nurseries. Artificial humidification inside theincubator hood can be used to decrease evaporative heat loss. However,there are significant disadvantages with convection incubators.Humidification levels of greater than about 50% can be associated withrisks of bacterial colonization, pseudomonas infections in preterminfants, sepsis and death. Incubator ports and doors can be opened andclosed once an hour in some nursery situations, which makes it verydifficult to maintain homeothermy in critically ill patients due to aconstant need to access the patient for management. Temperatureregulation for the smallest infants in a convection incubator in thefirst few days can also be very difficult because of the rapid drops intemperature as the incubator doors are opened to care for the infant. Inaddition, the entry of cool air followed by overdamping of theservo-control system on infant skin can lead to overshoot and undershootof mid-hood incubator air temperature for up to one hour after the doorhas been closed. These temperature insults for over or under thermalneutral temperature may become part of infant's routine experienceduring intensive care. In addition, incubator designs may not warmadequately a very low birth weight infant of, e.g., less than 1 kgparticularly early in life when evaporative losses are extremely high.

Current convection incubators generally attempt to minimize air flowvelocity, increase air temperature, increase water vapor pressure andhumidity, and maintain adequate wall temperature on the incubators.Studies of environment and climate control however have shown thatairflow velocities, capacity for humidification and wall temperatures onincubators can vary considerably between different incubators.

Use of radiant warmers which is an alternative current technology alsohas significant shortcomings in thermoregulation. Radiant heaters placedover an open bed provide good accessibility and visibility for care butcan lead to extensive heat losses through evaporation and convection.

Radiant warmers generally comprise an electrically heated metal alloywire coiled within a quartz tube. Metal alloys can emit wavelengths inmiddle portion of infrared spectrum (1000 nm to 3000 nm). Surroundingquartz enveloping the coils can absorb the infrared energy and re-emitelectromagnetic radiation in longer wavelengths (>3000 nm). At fullpower, some of infrared irradiance can be less than 100 mW/cm³ and nearinfrared irradiance at or near 10 mW/cm³. Under a radiant warmer, aninfant can have significant convective and evaporative heat loss whichcan be replaced in a non-homogeneous fashion by the radiant warmingelement located above the infant. Thus, some body parts can be heatedout of proportion to others. In addition, evaporative heat loss can besignificantly higher in moderately preterm and very preterm underradiant heater compared to convection incubators. Insensible evaporativewater loss can be up to 3.5 ml/kg/hr in incubators and up to 7 ml/kg/hrunder radiant warmers for infants less than 1 kg. Insensible evaporativewater loss can become similar to convection incubators for infantsgreater than 1 kg. The limitation of radiant warmers forthermoregulation is evident in detection of, e.g., up to 8.8% increasedmetabolic rate secondary to increased oxygen consumption seen in infantsunder radiant warmers compared to convective incubators, indicatingadditional burden on normal growth and development.

Other methods for thermoregulation in infants can include kangaroo careusing skin to skin contact with the mother or father. However, thistechnique can be inadequate in preterm infants. Rigid plastic body hoodsas heat shields, hybrid incubator/radiant warmer design, occlusiveplastic blankets and bags, use of water filled mattress, semiocclusiveartificial skin made of polyurethane dressings and petroleum emollienthave also been tried but can be inadequate in very preterm and extremelypreterm infants.

Despite all the efforts which currently consist of quickly drying theinfant, placing infant under radiant warmer in the delivery room,convective incubation during transport, use of plastic bags over theinfant and other measures taken, extremely low birth weight infants ofless than 750 g can routinely become hypothermic and can be prone toexcessive transepidermal evaporative and convective heat loss. Further,the rate of rewarming the infant can also have complications and risksfor developing infants.

In contrast, some embodiments of the devices, systems, and methodsrelating to neonatal and/or amniotic bath incubators as described hereincan provide significantly improved thermoregulation for infants byproviding a fluid environment with constant and uniform temperatures.

Improved Hydration

Not to be limited by theory, in addition to thermoregulation, anotherbenefit of some of the embodiments described herein can relate toimproved hydration of the infant through the intramembranous pathway. Innear term sheep, an average of 200-250 ml/day of water is generallyabsorbed from the amniotic sac directly into fetal blood. Similarly inhumans, a significant pathway for absorption of amniotic fluid by thefetus through diffusion of fluid across the fetal skin back into fetalcirculation has been observed and can be calculated at 200-500 ml/daynear term. This pathway of absorption of water is generally referred toas the Intramembranous Pathway. Fluid constantly absorbed by the fetuscan be mostly urinated and circulated back into the amniotic sac. Uponpreterm birth, this pathway of circulation of water can immediatelycease and the underdeveloped skin can be exposed to a harsh and dryenvironment of a nursery, where not only the intramembranous pathway ofabsorption of fluid is halted, but can be reversed through tremendousevaporative loss.

In utero, there can be a free flow of fluid across the skin and into thefetal plasma until the 26th week of gestation due to lack of developmentof the keratinized layer (intramembranous pathway). Fetal skin and theumbilical cord can be freely permeable to water and solutes, allowingrapid bidirectional diffusion across the non-keratinized layer.Keratinization of skin can begin at the 20th week and can be completedby the 26th week. Prior to this, an amniotic fluid can serve both as aphysiologic buffer and an extension of the fetal extracellularcompartment. Stratum corneum, which is responsible for epidermal barrierfunction does not become functionally mature in the fetus until 32 weeksgestation. However, acceleration of the skin maturing process can occurafter birth and exposure to air and most extremely premature infant candevelop an epidermal barrier by approximately 2 weeks of postnatal age.Overall, however, the skin of infants born 23 to 26 weeks' gestation isgenerally extremely immature and can be ineffective as an epidermalwater barrier. This can lead to disturbances in temperature regulation,water balance and breakdowns in skin integrity.

Premature infants who are less than about 30 weeks gestational age canexhibit water loss of as much as 15 times greater than that of full-terminfants because of their immature stratum corneum. Losses ranging from40 to 129 ml/kg/day or more have been reported. Some have estimatedpremature infant water loss at 26 weeks gestation or less in the first48 hours after birth at 60 g of water/m²/hr or greater than 180 ml/day.

This fluid loss can also leads to additional calorie burden ofapproximately 0.6 kcal/ml lost through latent heat evaporation. Thus, anextremely premature infant may lose 100 kcal/kg/day simply throughevaporation from the skin. Premature newborns 23-24 weeks gestationalage may lose as much as 13% of body weight as transepidermal water lossduring the 1st day of life, even at an ambient humidity of 50%.

Current medical practice generally does not provide for reconstitutionof the intramembranous pathway, but rather aims to reducetrans-epidermal evaporative water loss (TEWL). Currently in nurseriesthis approach is generally done through increasing the relative humiditysurrounding the infant. TEWL generally depends on the ambient watervapor pressure, irrespective of whether the infant is under a radiantwarmer or in an incubator. Raising the ambient humidity can increasewater vapor pressure and decrease fluid and heat loss throughevaporation. Because of high trans-epidermal fluid losses in theseinfants, intravenous solution containing 5% to 10% dextrose is generallystarted as quickly as possible after birth. Other strategies to reduceTEWL and prevent extreme heat and fluid losses in premature infantsyounger than 30 weeks gestational age can include transparent adhesivedressings and coating the skin with emollients. Transparent adhesivedressings can be used to prevent excessive skin water losses inpremature. TEWL can be reduced by as much as 50% by the creation of thissecond skin. However significant amount of skin trauma can occur upontheir removal. Smaller epidermal water loss can also be shown withemollient ointments.

The intramembranous pathway of circulation of water in humans isgenerally driven by osmotic differences between the amniotic fluid andthe fetal serum. A low amniotic fluid osmolality can provide a largepotential osmotic force: for example about 19.3 mm Hg for each mOsm/kggradient in osmolality across fetal skin. Artificial alteration of theosmolality and oncotic pressures of amniotic fluid has revealed thatintramembranous flow can be highly correlated to osmotic differences. Inanimal studies, direct infusion of saline into amniotic fluid on longterm basis in pregnant sheep has shown to increase fetal hydration.Injection of 1.5 L of warm distilled water into pregnant sheep amnioticfluid has shown significant absorption of fluid into fetal circulationleading to decrease in fetal osmolality, plasma electrolytes, fetalheart rate and increase in arterial pressure and fetal hemolysis showingintramembranous pathway (across the skin) as a major route of waterabsorption as a result of sudden change of amniotic fluid to a hypotonicsolution.

Some embodiments of the devices, systems, and methods of an amnioticbath incubator as described herein can provide for improved hydration topreterm infants or term infants by reconstituting the intramembranouspathway. To do so, in certain embodiments, a synthetic or simulatedamniotic bath in which an infant is placed in can comprise a lowosmolality to facilitate absorption thereof by the infant through theskin.

Supporting Musculoskeletal Development

Not to be limited by theory, in addition to thermoregulation andimproved hydration, another benefit of some of the embodiments describedherein relates to providing a better physiologic environment formusculoskeletal movement and development. In-utero, a fetus floats in anenvironment of amniotic fluid with near-zero gravity, which can provideroom for active movement and musculoskeletal exercise leading to normalmuscle tone at term. Muscle tone can be a major factor in how a pretermbaby's motor skills develop. A full-term infant with normal muscle tonecan keep itself in a nicely flexed position with arms and legs tuckedinto the body. A preterm infant, on the other hand, often has lessmuscle bulk and is usually hypotonic, making it difficult for the infantto achieve flexed positions. The infant can have difficulty resistinggravitational force, which is physiologically absent in the in-uterofluid environment for a fetus at this stage of development. Often, apreterm infant, unable to flex properly, may end up in frog-like postureor other postures for prolonged periods of time. These prolongedexposures to gravity can deprive the preterm infant of normal movementand exercise and thus can interrupt the infant's normal musculoskeletalgrowth and development.

When preterm infants are weak and hypotonic, especially through thetrunk, they can still attempt to gain some control by flexing orstiffening their muscles. They may arch their head, neck and trunk. Theymay lift their shoulders, make fists with their hands, and/or stiffentheir legs and point their toes. Only as they grow stronger and get morecontrol through the trunk, these other areas will start to relax.Preterm infants have been shown to exhibit motor delay when comparedwith their full-term peers, and also have also been shown to have someatypical postures, e.g. hyperextension of the neck and the trunk andreduced active flexion power when compared with their full-termcounterparts. These atypical postures are commonly believed to be causeddue to the loss of physiological flexion from premature birth andreinforcement of extended postures as a result of medical procedures inthe intensive care unit.

Not to be limited by theory, physiologically, while the primarydevelopment of muscle tissue can occur prior to term, differentiation ofmuscle fibers is considered incomplete until 40 weeks post-conception.Infants entering neonatal intensive care settings at 24 weeks'postconceptional age (PCA) can have incomplete development in muscletissue, extremity flexor tone, articular structures, skulls, and spinalcurvatures. These immature structures can contribute to vulnerabilityfor postural and skeletal malalignment. Early preterm infants born inless than 32 weeks are more likely to have delays in fine and grossmotor functioning. Flexor tone in the extremities of preterm neonatescan begin in the legs at 30 to 32 weeks' PCA and in the arms at 36weeks' PCA.

Studies of young adults examined at 14 and 23 years of age, who wereborn at very low birth weights (VLBW) of less than 1500 g, have showndiminished manual dexterity, reduced balance and reduced speed in grossmotor skills. Overall, VLBW young adults showed poorer fine and grossmotor skills compared to a control group. Longitudinal findings indicatethat many VLBW children do not outgrow their motor problems even afterentering adulthood. At the preschool age, prevalence of developmentaldelay in moderate preterm infants born between 32-35 weeks gestation wasabout twofold compared to full-term infants and about one-half comparedto early preterm infants.

Some of the embodiments described herein can prevent such results byproviding an infant with a more physiologic and natural environment fordevelopment and movement of the arms and legs. In certain embodiments,unlike convection incubators or radiant warmers, appendicular skeletonis no longer exposed to 1 G gravity or bundled/swaddled in blankets,thereby removing such obstacles to musculoskeletal development. The lowgravitational fluid environment of less than 1 G in some embodiments canallow a pre-term infant to continuously move and exercise itsappendicular skeleton similar to the in-utero environment, therebyproviding better support for musculoskeletal development and growth forthe infant.

Supporting Skin Development

Not to be limited by theory, another benefit of some of the amnioticbath incubator systems, devices, and methods described herein can relateto improved skin care and related protective advantages of fluidsubmersion.

Skin breakdown of premature infants can generally occur due to a varietyof causes, including trauma from adhesive removal, infection, friction,pressure sores from prolonged bedrest, and diaper dermatitis. The degreeof skin breakdown can range from surface excoriations to full thicknesswounds involving the dermis. Further, cutaneous manifestations often mayprecede systemic bacterial or fungal disease. Invasive fungal dermatitisis generally recognized as an early form of fungal disease in extremelylow-birth-weight infants.

Existing methods of care can involve use of various emollients toimprove skin integrity. Further, use of soft bedding and watermattresses has become one method of attempting to prevent pressurepoints on the skin. Moreover, periodic moistening of wounded tissueevery 4-6 hours can aid the healing process, whereas drying can impedethe migration of cells. However, such methods all have theirshortcomings.

Further, diaper dermatitis can be a significant risk, especially inpre-term infants. Diaper dermatitis can have a number of causes ininfants and can affect the perineum, groin, thighs, buttocks, and analregions. As the pH of the skin rises when exposed to urine or stool, theskin can become more vulnerable to injury and penetration bymicroorganisms. An alkaline pH can activate fecal enzymes, such asprotease and lipase, which can break down protein and fat, buildingblocks of the stratum corneum, and also activate bile salts that cancause injury. This can be a primary mechanism for direct contactdermatitis from exposure to stool.

Skin breakdowns and injuries can be a significant cause of morbidity inneonatal intensive care setting. Skin injuries can lead to discomfortand pain, infections, sepsis and death. A dry environment in which apreterm infant is exposed to is suboptimal in maintaining a hydrated andhealthy skin developing rapidly to prepare itself for the dryenvironment. As such, some of the embodiments herein provide a fluidenvironment to provide improved hydration to the skin as well as preventpressure injuries to the skin of preterm infants.

Overview

As discussed, devices, systems, and methods described herein can providea simulated fluid environment similar to the mother's womb to recreate amore familiar environment for infants, including infants born beforetheir ideal due date, low birth weight term infants, and/or normal birthweight term infants during the first 24 or 48 hours. The devices,systems, and methods described herein can provide for improvedthermoregulation, comfort, and hydration for pre-term, term, and/orolder infants. One or more such advantages, such as thermoregulation,can be particularly important before, during, and/or after surgicalprocedures. In some embodiments, an amniotic bath incubator can comprisean incubating tank with synthetic or simulated amniotic fluid, a heatingelement(s), a temperature sensor(s), and/or thermostat(s) fortemperature regulation. An infant or premature infant can be placed inthe incubating tank to provide a thermo-regulated fluid environment tothe infant, in which the fluid can be made similar to physiologicamniotic fluid. For example, the osmolality, electrolyte and mineralcontent of the synthetic or simulated amniotic fluid in which the infantis placed can be similar to those of physiologic amniotic fluid.

The physiologic amniotic fluid in the mother's womb is the protectiveliquid bathing the fetus during pregnancy and serves as a heat reservoirfor thermoregulation and a reservoir for absorption of water by thefetus through the intramembranous pathway. It also provides anenvironment for fetal movement and comfort while maintaining a steadytemperature of 37 C for the developing infant. Amniotic fluid containselectrolytes, minerals, proteins, peptides, lipids, lactate, pyruvate,enzymes, hormones and amniotic stem cells.

As such, in some embodiments, the temperature of the synthetic orsimulated amniotic bath is regulated by use of one or more temperaturesensors and/or heaters to maintain a temperature of about 37° C. for theinfant. The synthetic or simulated amniotic fluid can also comprise oneor more electrolytes, minerals, proteins, peptides, lipids, lactate,pyruvate, enzymes, hormones and amniotic stem cells.

FIG. 1 illustrates a perspective view of an infant placed inside anembodiment of an amniotic bath incubator. In some embodiments, an infantor preterm infant sits in the simulated or synthetic amniotic fluid 13C.For example, the infant or preterm infant can be placed in the syntheticamniotic fluid 13C up to its sternal notch, or neck in some embodiments.

System/Device Components

FIG. 2 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants. Referring to FIG. 2, in someembodiments, a neonatal incubator 10 for term and preterm infantsaccommodates the infant's body and extremities submerged in syntheticamniotic fluid 94, thereby creating a womb-like condition for theinfant. The incubator 10 can comprise a bath 12 for holding the infantand the synthetic amniotic fluid 94.

In some embodiments, the bath 12 can be supported on a frame 14, whichcan also house a fresh fluid reservoir 16, a waste fluid primary tank18, and/or a waste fluid secondary tank 20. In certain embodiments, toconserve heat and preserve the synthetic amniotic fluid 94 when theinfant is placed in the bath 12, a dome 22, preferably made of a clearmaterial such as acrylic glass, covers the bath 12. One or more sleeveports 24 may be incorporated into the dome 22 for accessing andmanipulating the infant from a variety of positions while maintainingthe dome 12 over the infant.

In some embodiments, the frame 14 can comprise a support 26,incorporating functions for dispensing water and synthetic amnioticfluid 94, and/or a sliding shelf 28. The frame can also comprise panels30 to protect the reservoir 16, the primary tank 18 and secondary tank20, and guides 32 that interface with the reservoir 16 and the primaryand secondary tanks 18, 20 to preserve their orientation relative to theframe 14.

FIG. 3 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants with the dome removed. Referring toFIG. 3, the incubator 10 of an embodiment is shown with the dome 22removed. In some embodiments, the bath 12 comprises a seatback 34 and/ora post 36 for holding the infant in a comfortable position. The seatback34 and/or post 36 can be located in a sump portion 40 of the bath 12,which can be surrounded by a shallow portion 42. The shallow portion 42can be bordered by a raised rim 44.

In certain embodiments, a gutter 46 catches any synthetic amniotic fluid94 escaping over the raised rim 44. A bumper 48 can surround the bath 12to suppress jarring vibrations if the incubator 10 inadvertently strikesa surface when moved. The bath 12 can be filled via a spout 50 extendingover the raised rim 44, and temperature can be maintained using aheating element within the bath 12. The bath can also incorporate adrain in the sump portion 40 for draining the bath 12. In someembodiments, some or all internal pipes and/or tubes or a portionthereof of the amniotic bath incubator system comprise only negativeangles to facilitate natural draining of residual fluid to thewastewater tank to reduce risk of colonization with bacteria.

In some embodiments, the spout 50 is operated using a water control 52and/or an amniotic fluid control 54. The water and amniotic fluidcontrols 50, 52 can be located on the support 26, although they may berepositioned according to preference and design. Additional controls 56can be included for other purposes, such as draining the bath 12,heating, maintain temperature, cooling/heating the bath, adding purifiedwater, dissolving one or more cartridges, etc. In certain embodiments,one or more controls, including the water and/or amniotic fluid controls50, 52 can be located on a device separate from the amniotic bath, inwhich the one or more controls can be configured to electronicallycommunicate with one or more components of the amniotic bath. Forexample, the one or more controls can be part of a single device that isconfigured to control one or more functions of a plurality of amnioticbath incubators. As such, an operator may be able to control one or morefunctions of a plurality of amniotic bath incubators at once from asingle location. The one or more functions can include, for example,changing or rinsing the bath fluid, preparing the bath fluid,disinfection, discharging wastewater, replacing fresh water, or anyother feature described herein. In addition to the guides on the frame14, an upper central panel 58 may be located between the reservoir 16,and the primary and secondary tanks 18, 20, to help orient them andpreserve their position relative to the frame 14. A sensor readout 60positioned under the upper central panel 58 can include data about thecondition of the incubator 10 and synthetic amniotic fluid 94.

FIG. 4 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants with the dome removed. Referring toFIG. 4, the bath 12 may incorporate a removable cover 62. In someembodiments, the cover 62 can conform to the shape of the bath 12, itssump portion 40, seatback 34 and/or post 36, as well as the shallowportion 42 comprising the raised rim 44, and be pre-formed in theaforementioned shape in some cases. In certain embodiments, the cover 62may constitute the raised rim 44, and/or surface features 38 forstimulation. In order to prevent any synthetic amniotic fluid 94 frombecoming trapped under the cover 62, the bath 12 may include one or moredrain ports 64 leading to the primary waste tank 18. The cover 62 canprimarily drain through a conforming drain aperture 65, which canconform to the drain at the bottom of the sump portion 40 of the bath12.

With the seatback 34 and/or post 36, the bath 12 can be formed similarto an infant seat and may be made in different sizes for different sizedinfants to allow comfortable positioning of the infant in a near seatedposition, allowing the infant's head to be comfortably positioned abovethe fluid level to allow oral nutrition and airway oxygenation. Thesizes can correspond to differences in height and weight of preterm andterm infants. In some embodiments, the system can comprise a pluralityof covers 62 of varying sizes. The plurality of covers 62 of varyingsizes can each comprise configurations of a seatback 34 and/or post 36of varying sizes to accommodate infants of different sizes. As such, anoperator may be able to select a particular cover 62 comprising aseatback 34 and/or post 36 of particular size(s) to fit a particularinfant. Likewise, different covers 62 of varying sizes may be usedreplaced and used for the same infant as the infant grows.

The cover 62, like the bath 12 can be sterile and also made in differentseat sizes fit for the tank and infant seat. Specifically, the cover 62can be made of a medically inert material that may include antibacterialand antifungal properties, and a safety strap to prevent accidentalsubmersion. A conforming drainage aperture 65 that aligns with theoutflow channel of the sump portion 40 can be opened and closed using astopcock or another similar mechanism to refill the cover 62 withsynthetic amniotic fluid 94 when reusing the cover 62 as clinicallyindicated. The sterile synthetic amniotic fluid 94 with or withoutadditional medications or nutrients can enter the reservoir through thespout 50. Alternatively, separately from the incubator 10, it may bepoured into the cover 62 using piping or a shower attached to inflowpiping.

In some embodiments, the sensor readout panel 60 can be located on alower central panel 66. The sensor readout panel 60 can be located onany other portion of the amniotic bath incubator. In certainembodiments, the sensor readout panel 60 can be located on anotherdevice separate from the amniotic bath incubator, in which the separatedevice is configured to electronically communicate with one or morecomponents of the amniotic bath incubator. For example, a userinterface, such as a smartphone, tablet, laptop, or other computerdisplay, may be configured to display one or more sensor readouts. Thelower central panel 66 can include a reservoir release pedal 68 and/or awastewater release pedal 70, keeping the reservoir 16, the primary tank18, and the secondary tank 20 in position when the incubator 10 ismoved. In some embodiments in which the reservoir 16 and the secondarytank 20 are on casters 72, they can roll out from under the frame 14 fordisposal and/or refilling operations.

FIG. 5 illustrates a perspective view of an embodiment of an amnioticbath incubator for premature infants with a changing panel extended.Referring to FIG. 5, the incubator is shown with the sliding shelf 28extended. The sliding shelf 28 can comprise one or more support ribs 74allowing it to hold substantial weight. A raised lip 76 can help preventobjects from rolling or sliding off the sliding shelf 28.

Referring to FIG. 6, the amniotic bath incubator can comprise areservoir 16, which can be a high volume container on casters 72 formobility. A liquid level indicator 78 can be provided to alert userswhen the reservoir 16 needs refilling. In some embodiments, thereservoir 16 can comprise one or more level sensors configured to detectthe level of fluid in the reservoir 16. For example, the reservoir 16can comprise a top level detector and/or a low level detector. A toplevel detector can be configured to determine when the fluid level ofthe reservoir 16 is at or above a predetermined level, and a low leveldetector can be configured to determine when the fluid level of thereservoir 16 is at or below a predetermined level. When a fluid level ofthe reservoir 16 is detected to be below a predetermined level, thesystem can be configured to sound an alarm and/or electronicallytransmit and cause an alarm, whether visual or acoustic, to prompt anoperator to fill the reservoir 16. In certain embodiments, the reservoir16 can be directly connected to a water supply. When a fluid level ofthe reservoir 16 is detected to be below a predetermined level, thesystem can be configured to automatically refill the reservoir 16 from awater supply.

A series of slots 80 can be incorporated into the reservoir 16 forengaging the guides 32 on the frame 14. At the top of the reservoir 16,a recessed articulating reservoir handle 82 can allow lifting ordirecting the reservoir 16 on the casters 72 in and out of the incubator10. A filling tube 84 can be incorporated into the reservoir 16 to allowusers to replenish it with fresh or sterile fluid, and an amnioticcontainer port 86 can be provided for introducing an amniotic fluidsupply 88. Opposite the liquid level indicator 78, a hose bin 90 can besized to hold the filling tube 84 when not in use. In certainembodiments, the reservoir 16 can be directly 6 connected to a freshwater line, for example in a hospital, and can include an automated ornon-automated on/off valve to hold a constant predetermined amount ofwater in the reservoir 16.

Referring to FIG. 7, the internal components of the reservoir 16 areshown. A filling tube 84 can be adapted for coupling to a water supply.The water supply can be configured to supply and/or comprise purifiedwater, such as sterile and/or de-ionized water for example. In certainembodiments, the water supply can be configured to supply and/orcomprise reserve-osmotic treated water. A synthetic amniotic fluidsupply 88 can fit through an amniotic container port 86, and engage avalve 92 allowing a concentrated synthetic amniotic fluid 94 to mix withfluid in the reservoir 16 at predetermined rate. Mixing can becalibrated to create a fluid having component concentrations(osmolality, mineral, vitamin, electrolyte, amino-acid, protein,hormone, phospholipids, lipids, oxygen or other gas content, etc.)similar to natural amniotic fluid produced by the mother. In otherembodiments, the synthetic amniotic fluid 94 may include nutrients andpharmaceutical compounds not found in natural amniotic fluid but whichmedically beneficial or necessary for care of the infant.

In order to preserve the temperature of fluid in the reservoir 16, aheating element 96, connected to a power supply 98 may be provided. Inorder to maintain sterility or near sterility, the synthetic amnioticfluid 94 may be continuously pumped through a filter 100, comprising aUV or similar system to clear it from debris, contaminants, bacteria,viruses and fungi. A pump 102 can urge fluid from the reservoir 16 up tothe bath 12. In some embodiments, a valve system 104 can alsocontemplated for continuously mixing synthetic amniotic fluid 94. Insuch embodiments, the reservoir 16 can include a water bib 106 thatpumps pure water and/or an amniotic fluid bib 108 that pumps apredetermined mixture of water and synthetic amniotic fluid 94.

Referring to FIG. 8, an amniotic fluid supply 88 can be removed throughthe amniotic container port 86 when empty and/or be replaced with a newamniotic fluid supply 88 filled 7 with concentrated synthetic amnioticfluid 94. The synthetic amniotic fluid 94 may have a predeterminedosmolality, mineral content, vitamin content, electrolyte content,amino-acid content, protein content, hormone content, phospholipidcontent, including lipids, and an oxygen or gas content similar tonatural amniotic fluid. It may also be adjusted according to medicalneeds of the infant. Additional fluid, nutrients and pharmaceuticals canbe added to the synthetic amniotic fluid 94 for transdermaladministration of fluids, nutrients and pharmaceuticals in a preterminfant through submerging of body in fluid. The non-keratinized thindermal and epidermal layer in preterm infant skin can allow passage offluid and molecules unlike keratinized and thicker skin of term andadult humans which can allow for application of nutrients andpharmaceuticals.

Referring to FIG. 9, a wastewater primary tank 18 is shown. A primarytank 18 can comprise a second liquid level indicator 78, a primary tankhandle 112, and/or a wastewater inlet 114 in communication with the bath12. A wastewater spout 116 having a wastewater valve 118 can be incommunication with a secondary tank 20. When the secondary tank 20 isremoved, the wastewater valve 118 may be closed allowing wastewater tocollect in the primary tank 18, thereby avoiding interruption ofamniotic incubation. The second level indicator can be monitored to makesure the wastewater valve 118 is reopened to the secondary tank 20before the primary tank 18 overflows. Regardless of the presence orabsence of the secondary tank 20, the primary tank 18 can also beremoved from the frame 14 using the primary tank handle 112 forindependent disposal of wastewater and cleaning.

In some embodiments, the wastewater tank, wastewater primary tank 18,and/or wastewater secondary tank 20 can comprise one or more levelsensors configured to detect the level of fluid in the wastewater tank,wastewater primary tank 18, and/or wastewater secondary tank 20. Forexample, the wastewater tank, wastewater primary tank 18, and/orwastewater secondary tank 20 can comprise a top level detector and/or alow level detector. A top level detector can be configured to determinewhen the fluid level of the wastewater tank, wastewater primary tank 18,and/or wastewater secondary tank 20 is at or above a predeterminedlevel, and a low level detector can be configured to determine when thefluid level of the wastewater tank, wastewater primary tank 18, and/orwastewater secondary tank 20 is at or below a predetermined level. Whena fluid level of the wastewater tank, wastewater primary tank 18, and/orwastewater secondary tank 20 is detected to be above a predeterminedlevel, the system can be configured to sound an alarm and/orelectronically transmit and cause an alarm, whether visual or acoustic,to prompt an operator to empty the wastewater tank, wastewater primarytank 18, and/or wastewater secondary tank 20. In certain embodiments,the wastewater tank, wastewater primary tank 18, and/or wastewatersecondary tank 20 can be directly connected to a sewage or disposalline. When a fluid level of the wastewater tank, wastewater primary tank18, and/or wastewater secondary tank 20 is detected to be above apredetermined level, the system can be configured to automaticallydispose contents of the wastewater tank, wastewater primary tank 18,and/or wastewater secondary tank 20 to the sewage or disposal line orother tank.

Referring to FIG. 10, a wastewater secondary tank 20 is shown. Similarto the reservoir 16, the secondary tank 20 can comprise casters 72 forindependent rolling and slots 80 for engaging the frame 14 andpreserving the secondary tank 20 in alignment with the primary tank 18.Although the secondary tank 20 can be larger than the primary tank 18,it can comprise a third level indicator 120 to alert users when thesecondary tank 20 is nearly full. The secondary tank 20 can comprise arecessed first secondary tank handle 122 and/or a second secondary tankhandle 124. The first secondary tank handle 122 can articulate like thereservoir handle 82. The second secondary tank handle 124 can bestationary like the primary tank handle 112. Together, they can allow auser to conveniently and easily empty the secondary tank 20 when full.In some embodiments, the wastewater primary tank 18 and/or secondarytank 20 can comprise one or more rechargeable batteries or other powersupply and/or one or more pumps for disposal of the wastewater content.In certain embodiments, the system comprises a single wastewater tankthat comprises one or more rechargeable batteries or other power supplyand/or one or more pumps for disposal of the wastewater content. Therechargeable battery or other power supply can be built into thewastewater primary tank 18, secondary tank 20, and/or single wastewatertank and/or can be selectively attached onto the wastewater primary tank18, secondary tank 20, and/or single wastewater tank for use.

A secondary wastewater inlet 126 can accept wastewater from thewastewater spout 116 of the primary tank 18, once the secondary tank 20is full, as measured by a third level indicator 120. In certainembodiments, the secondary tank 20 can be removed from the frame 14,emptied, cleaned, and replaced for further use. The secondary tank 20can also include a registration point 128 for aligning it with theprimary tank 18.

Referring to FIG. 11, a bath 12, primary tank 18, and secondary tank 20are shown in section view. In some embodiments, in this view, acomplimentary registration point 130 is shown on the primary tank 18 foraligning with the registration point 128 on the secondary tank 20. Whenthe secondary tank 20 is full of contaminated amniotic fluid 132, it canbe dispensed through an emptying spout 134 near the secondary wastewaterinlet 126.

In order to employ the incubator 10 when caring and maintaining apremature infant, a user can supply power to the incubator 10 and fillthe reservoir 16 with fluid, such as water, which may be sterile,de-ionized, and/or otherwise purified. In some embodiments, thereservoir 16 can be released using the fresh water release pedal 68,which can allow a user to roll the reservoir 16 out from the frame 14along the guides 32. The reservoir 16 can be rolled to a desiredlocation for filling remotely from the incubator 10. While filling thereservoir 16, the liquid level indicator 78 may be monitored to ensure aproper volume of fluid and prevent overfilling. The filling tube 84 maybe used to conveniently fill the reservoir 16 from a sink, or otherdifficult to reach location. In certain embodiments, the reservoir 16can be configured to automatically fill fresh water as necessary from awater supply. For example, when one or more sensors of the reservoir 16detect that the water level of the reservoir 16 is below a predeterminedlevel, the system can be configured to automatically open one or morevalves to refill the reservoir from a water supply.

Cover/Liner

Referring back to FIG. 1, in some embodiments, the amniotic bathincubator can comprise a cover or liner 1C. The cover 1C can be sterileand/or made replaceable. The cover 1C can be made of plastic. A nurse orhealth care provider can replace the cover periodically, for exampleabout, at least about, or no more than about once every about 1 hour,about 2 hours, about 3 hours, about 4 hours, about 5 hours, about 6hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours,about 11 hours, about 12 hours, about 13 hours, about 14 hours, about 15hours, about 16 hours, about 17 hours, about 18 hours, about 19 hours,about 20 hours, about 21 hours, about 22 hours, about 23 hours, about 24hours, about 36 hours, about 2 days, about 3 days, about 4 days, about 5days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 4weeks, and/or within a range defined by two of the aforementionedvalues. In certain embodiments, the cover can be replaced as necessary.

In some embodiments, the cover or liner 1C can comprise or be configuredto be used in conjunction with one or more safety straps or harnesses15C for substantially maintaining the position of the infant. Forexample, the one or more safety straps or harnesses 15C can beconfigured to prevent accidental submersion of the infant in the fluid.

In certain embodiments, the cover or liner can comprise a general shapeor configuration for providing sufficient support to an infant to sit upin the bath without being submerged. For example, the cover or liner 1Ccan comprise a depression of a general shape that allows for the infantto sit. As discussed above, the cover 1C can comprise a seatback and/ora post. A plurality of covers 1C of the same size may be provided forperiodic replacement. In certain embodiments, a plurality of covers 1Cof a generally same shape but different sizes may be provided forreplacement as the infant grows. In some embodiments, a plurality ofcovers 1C can comprise different sizes and/or configurations tosubstantially match and/or accommodate adapters of different sizesand/or configurations.

Amniotic Fluid Disposal Unit

In some embodiments, the cover or liner 1C can comprise and/or beconfigured to be used in conjunction with an amniotic fluid disposalunit. FIG. 11A illustrates an embodiment of an amniotic fluid disposalunit. The amniotic fluid disposal unit can be configured to perform theamniotic bath fluid change or a portion thereof. More specifically, theamniotic fluid disposal unit can be configured to collect and/or removestool, urine, and/or contaminated synthetic amniotic fluid from theamniotic bath. The collected stool and/or contaminated syntheticamniotic fluid can be configured to be disposed into the wastewatertank. In some embodiments, the amniotic fluid disposal unit can be anintegral part of the disposable cover or liner 1C.

The amniotic fluid disposal unit can comprise one or more stoolcollectors 1D, bath fluid inflow portions 9D, filters 11D, protectivenets 3D, contamination sensors, and/or plug units 5D for the drainvalve. The stool collector 1D can be donut-shaped in some embodiments.The stool collector 1D can be configured to be loosely positioned on oraround the skin of the patient or infant in a manner such that itsubstantially surrounds the buttocks, anus, and/or external urethralorifice. The stool collector 1D may reduce the ability of fluid to flowbetween the amniotic fluid disposal unit and bath in the area of contactof the stool collector 1D and the skin of the patient or infant. Stoolor urine from the infant or patient can be collected by the stoolcollector 1D. More specifically, in some embodiments, stool, urine,and/or amniotic fluid to be disposed can be collected by the stoolcollector 1D and flow through one or more filters to a drain valve.Amniotic fluid to be disposed can flow through the bath fluid inflowportion 9D and through one or more filters to a drain valve.

The bath fluid inflow portion 9D can comprise an opening configured toallow used and/or contaminated synthetic amniotic fluid to flow out ofthe bath. The bath fluid inflow portion 9D can further comprise one ormore filters 11D. The one or more filters 11D can be positioned afterthe inflow opening and can be configured to prevent backflow of stooland/or fluid to be disposed back into the bath as stool is collecteddownstream of the one or more filters 11D.

In some embodiments, the stool collector 1D can comprise and/or beconfigured to be used in conjunction with one or more protective nets3D. A protective net 3D can be configured to be positioned in the stoolcollector 1D. The protective net 3D can be configured to prevent suctionof one or more portions of the body of the infant or patient, whileallowing stool to pass through the protective net 3D.

In certain embodiments, one or more contamination sensors of theamniotic fluid disposal unit can be configured to detect, directly orindirectly, a contamination level of the synthetic amniotic fluid. Insome embodiments, a bath fluid change process can be initiated when thedetected contamination level is at or above a predeterminedcontamination level.

In some embodiments, the drain valve can be configured to open and/orclose a drain line towards a wastewater tank of the system. In certainembodiments, the disposable bath cover or liner 1C can comprise a drainvalve plug unit 5D and/or seat or ring 7D. The drain valve plug unit 5Dand/or seat or ring 7D can be an integral part of the disposable bathcover 1C. The drain valve can also comprise a stem portion 13D, one ormore seals, and/or actuators. The stem 13D, seal and/or actuator can bepermanently attached to the amniotic bath incubator system. The plugunit 5D of the drain valve can be attached by a push/pullconnector-fitting to the stem portion 13D of the valve duringinstallation of the disposable bath cover 1C. When one or more sensorsdetect that the contamination level of the bath fluid is at or above apredetermined level that requires partial or complete change of theamniotic bath fluid, the control unit of the system can power theactuator of the valve. The plug unit 5D can then open, allowing theamniotic fluid along with stool to flow out of the amniotic bath throughthe amniotic fluid disposal unit.

Adapter Seat

In some embodiments, the amniotic bath incubator system can comprise anadapter seat. FIG. 11B illustrates an embodiment of an adapter seatattached to an amniotic bath incubator system. The adapter seat 5E canbe configured to be placed beneath the cover or liner 1C. In someembodiments, the system can comprise a plurality of adapter seats 5E.The plurality of adapter seats 5E can comprise different configurationsand/or sizes, for example to accommodate infants of different sizes. Byproviding a plurality of adapter seats 5E of different sizes, in someembodiments, a single amniotic bath incubator system can be adapted foruse with infants of different sizes by replacing and/or attaching anadapter seat 5E that substantially matches the size of the infant to beseated in the bath. Accordingly, a single size bath mold may be used toproduce an amniotic bath incubator in certain embodiments with aplurality of replaceable adapter seats 5E of varying sizes. In someembodiments, the adapter seat 5E can comprise a soft and/or comfortablematerial. For example, the adapter seats can comprise a jell-likematerial.

The surface of the adapter 5E that faces towards the patient or infantcan be configured to be in contact with the infant or patient. Theoverall design of the surface of the adapter 5E that faces towards thepatient or infant can assure substantially equal level of comfort andsafety to a smaller patient as a larger patient would feel without theadapter 5E. Other surfaces of the adapter 5E not facing and/or not incontact with the patient or infant can be designed to assure fullfunctionality of the bath and can comprise one or more lockingmechanisms for attaching and detaching the adapter 5E from the bath.

In some embodiments, the amniotic bath incubator can be configured to beused without attachment of an adapter seat 5E for infants of a certainsize. For example, in certain embodiments, the amniotic bath incubatorcan be configured to be used without attachment of an adapter seat 5Efor infants at or above a certain size, such as about 60 cm or 65 cm inheight. For infants below a certain size, such as about 60 cm or 65 cmin height, the amniotic bath incubator can be configured to be used withattachment of an adapter seat 5E to accommodate for the size of thesmaller infant. In certain embodiments, one or more adapters 5E can beconfigured to be used with infants of sizes between about 25 cm andabout 65 cm in height. In certain embodiments, an operator or caregivercan place an adapter seat 5E of an appropriate size before placing aninfant in the amniotic bath incubator.

The cover or liner 1C can be configured to substantially match theconfiguration and/or size of the adapter seat 5E. In certainembodiments, the system can further comprise a plurality of covers orliners 1C of different configurations and/or sizes to substantiallymatch the plurality of adapter seats 5E.

Fluid Sensor

In certain embodiments, the amniotic bath incubator system can comprisea fluid sensor 17C configured to detect presence of fluid. For example,the fluid sensor 17C can be configured to be worn around the neck of theinfant inside the bath. The fluid sensor 17C can be configured to senseaccidental submersion of the infant (e.g., the infant's head) in thefluid, which can result in automatic lowering of fluid level. In someembodiments, one or more fluid sensors can be worn or placed on otherparts of the infant's body that is desired not to be submerged in thefluid, such as the face of the infant.

Bridges/Mounts

Referring again to FIGS. 1 and 11B, in some embodiments, the cover 1Ccomprises one or more bridges or mounts 3C, 5C, 1E and/or is configuredto be used in conjunction with one or more bridges or mounts 3C, 5C, 1E.The one or more bridges or mounts 3C, 5C, 1E can be configured to belocated above the bath. In certain embodiments, the height of the one ormore bridges or mounts 3C, 5C, 1E can be changed. For instance, the oneor more bridges or mounts 3C, 5C, 1E can comprise and/or be connected toone or more motors or actuators for increasing and/or decreasing theheight of the one or more bridges or mounts 3C, 5C, 1E. The height ofthe one or more bridges or mounts 3C, 5C, 1E as measured from a topsurface of the cover 1C and/or as measured the fluid level, can be, forexample, about, at least about, or no more than about 1 cm, about 2 cm,about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm,about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm,about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about45 cm, about 50 cm, and/or within a range defined by two of theaforementioned values.

The one or more mounts 3C, 5C, 1E can be configured to maintain one endof one or more tubes above the fluid. In certain embodiments, the heightof the one or more bridges or mounts 3C, 5C, 1E can be changed accordingto a desired height based on the attached one or more tubes. Forexample, the one or more tubes can be one or more of an umbilical tube,a feeding tube, an oxygen tube, intravenous (IV) tube, or the like. Morespecifically, in some embodiments, the umbilical cord of a preterminfant can be cut relatively long compared to that of term infantsand/or compared to current practice. One end of one or more umbilicaltubes can then be configured to be connected to the umbilical cord ofthe preterm infant sitting inside the amniotic fluid bath to providenutrients, oxygenation, medicine or the like and/or for sampling ofblood or the like of the infant, for example for laboratory testingpurposes. The umbilical cord can be attached to a bridge above the fluidlevel such that catheters and/or tubes inserted into the umbilical cordare not in contact with the fluid. In another embodiment, a clear,sterile, and/or plastic cover, which can be similar to a sterileultrasound probe cover for example, can be placed on the catheter and/orother lines. In certain embodiments, such cover can be fastened and/oranchored to the umbilical cord to prevent contamination of the catheterand/or other line with amniotic fluid in case of accidental submersionof the umbilical catheter within fluid. Similarly, an IV tube can beconnected to a vein of the infant sitting inside the amniotic fluid.Likewise, a feeding and/or oxygen tube can be connected to the mouth ofthe preterm infant. In any case, it can be advantageous to ensure thatthe other end of the tube(s) that is not connected to the infant is notsubmerged in the fluid and/or comprises a sterile and/or plasticcovering in case of accidental submersion to prevent the synthetic fluidfrom entering the tube(s) and/or contamination or infection. As such, incertain embodiments, the other end of the tube(s) not connecting to theinfant is anchored or otherwise set in place above the syntheticamniotic fluid by attaching to a bridge or mount 3C, 5C, 1E to ensurethe one or more tube(s) do not become infected and keep them sterile.

In some embodiments, the amniotic bath incubator system comprises asingle bridge or mount 1E. In certain embodiments, the amniotic bathincubator system comprises a first bridge or mount 3C for maintainingthe position of one or tubes configured to be connected to the mouth ofthe infant, such as a feeding tube and/or oxygen tube, and a secondbridge or mount 5C for maintaining the position of one or more tubesconfigured to be connected to the umbilical cord of the infant. Incertain embodiments, the amniotic bath incubator system comprises threeor more bridges or mounts 3C, 5C, 1E.

In certain embodiments, the bridge or mount can comprise a first sidesegment, a second side segment, and a top segment. The first sidesegment and/or the second side segment can extend upward from one ormore edges of the amniotic bath in a vertical direction perpendicular toa top surface of the bath and/or bath fluid. The top segment or beam canbe parallel to the top surface of the bath and/or bath fluid and cantraverse a longitudinal or latitudinal axis of the incubator. The firstside segment, second side segment, and/or top segment or beam can besubstantially straight, curved, and/or angular. The first side segment,second side segment, and/or top segment or beam can be configured toconnect only two of four outer sides of the periphery of a rectangulartop surface of the bath. The first side segment, second side segment,top segment or beam, and the top surface of the bath can comprise anopen space, as opposed to a closed space formed by a dome placed overthe bath.

In some embodiments, the one or more bridges or mounts 3C, 5C, 1E can bean umbilical catheter bridge. An umbilical catheter bridge can bespecifically designed to hold and/or guide an umbilical catheter line.The umbilical catheter bridge or one or more bridges or mounts 3C, 5C,1E can be configured to be easily attached and/or detached form theamniotic bath incubator system. For example, in some embodiments, theumbilical catheter bridge or one or more bridges or mounts 3C, 5C, 1Ecan comprise one or more attachment mechanisms 3E for attaching and/orreleasing from the amniotic bath incubator.

Modular Configuration

In some embodiments, the amniotic bath incubator system and/or devicecan comprise a modular configuration. In other words, one or morecomponents of the system can be a module, allowing for easy replacementand attachment. For example, in certain embodiments, the system cancomprise one or more fluid tanks, freshwater or purified water tanks,amniotic fluid tanks or bath, wastewater tanks, covers, domes, or thelike that are modular or comprise one or more modules.

In certain embodiments, the one or more wastewater tanks, freshwater orpurified water tanks, and/or amniotic bath fluid tanks can be configuredto be connected to a water line and/or sewage line. In such embodiments,fresh or purified water can be continuously and/or periodically beprovided to the freshwater or purified water tank directly. In someembodiments, the fresh or purified water tank can comprise one or moresensors for detecting a fluid level within the tank. In certainembodiments, the fresh or purified water tank can be configured toautomatically refill the tank with fresh and/or purified water when thefluid level within the tank is at or below a predetermined level, suchas at or below 10%. Similarly, wastewater can be continuously and/orperiodically be removed from the wastewater tank directly into a sewageline or other waste tank. In some embodiments, a wastewater tank cancomprise one or more sensors for detecting a fluid level within thetank. In certain embodiments, the wastewater tank can be configured toautomatically dispose its contents when the fluid level within the tankis at or above a predetermined level, such as at or above 90%.

In certain embodiments, the one or more wastewater tanks and/orfreshwater or purified water tanks are not connected to a water lineand/or sewage line. In such embodiments, the one or more wastewatertanks and/or freshwater or purified water tanks can be configured to beremoved from the system for refilling and/or disposal. After removing,the one or more wastewater tanks and/or freshwater or purified watertanks can be moved to a location that allows for addition or purified orfresh water and/or removal of wastewater. For example, in someembodiments, the one or more waste water tanks and/or freshwater orpurified water tanks can comprise one or more rollers or wheels. A usermay be able to utilize the one or more rollers or wheels to easily movethe one or more freshwater or purified water tanks to a water supplysource to add water. Similarly, a user may be able to utilize the one ormore rollers or wheels to easily and conveniently move the one or morewastewater tanks to a location for wastewater removal, such as a sewageline, to remove the wastewater. In some embodiments, the fresh orpurified water tank can be configured to automatically alert anoperator, for example through visual and/or audio alerts, when the fluidlevel within the tank is at or below a predetermined level, such as ator below 10%, to prompt the operator to refill the tank. In certainembodiments, the wastewater tank can be configured to automaticallyalert an operator, for example through visual and/or audio alerts, whenthe fluid level within the tank is at or above a predetermined level,such as at or above 90%, to prompt the operator to empty the tank.

In some embodiments, the system can comprise a plurality of wastewatertanks and/or fresh water or purified water tanks. For example, anamniotic bath incubator can comprise two or more wastewater tanks and/orfresh or purified water tanks. As such, in certain embodiments, whileone of the two or more wastewater tanks and/or fresh or purified watertanks are being refilled or emptied, the amniotic bath incubator maycontinue to comprise at least one wastewater tank and/or fresh orpurified water tank.

In certain embodiments, an operator may switch out or replace one ormore wastewater tanks and/or fresh or purified water tanks withpre-filled or pre-emptied wastewater tank and/or fresh or purified watertank. For example, after removing an emptied or nearly emptied freshwater or purified water tank, the operator may immediately replace theamniotic bath incubator with another fresh or purified water tank thathas already been filled. As such, the amniotic bath incubator cancontinue to comprise at least one functioning fresh or purified watertank while the original emptied tank is being filled. Similarly, afterremoving a full or nearly full wastewater tank, the operator mayimmediately replace the amniotic bath incubator with another wastewatertank that is not full or is empty. As such, the amniotic bath incubatorcan continue to comprise at least one functioning wastewater tank whilethe original wastewater tank is being emptied.

In some embodiments, the one or more fresh or purified water tanks cancomprise one or more handles and/or wheels for easy transport to nearbybathwater sink. The one or more fresh water tanks can comprise adisposable hose to allow easy filling of the tank from the sink faucet.The water can be purified of impurities, electrolytes, minerals andbacteria through a deionization and/or reverse osmosis filtrationsystem. The deionization filtration system can be built into theamniotic bath system or device in some embodiments. In otherembodiments, the amniotic bath system or device can be configured to beused in conjunction with a separate deionization and/or reverse osmosisfiltration system.

The freshwater tank can comprise a sterile cover. The sterile cover canbe made of plastic or metal and can be disposable. For example, thesterile cover of the freshwater tank can be configured to be replacedabout, at least about, or no more than about once every about 3 hours,about 3 hours, about 6 hours, about 9 hours, about 12 hours, about 15hours, about 18 hours, about 21 hours, about 24 hours, about 36 hours,about 48 hours, and/or within a time range defined by two of theaforementioned values. The sterile cover can also be configured to bereplaced with every refill of the tank.

The waste fluid tank can comprise a filter to collect the stool andsolids from the waste. The filter can be replaceable and/or disposable.In some embodiments, the waste fluid can sit on a disposable plasticcover. In certain embodiments, the wastewater tank can comprise one ormore pumps and/or hoses for easy disposal of the wastewater fluid into asink or sewage. The one or more pumps can be powered by a power source,such as a rechargeable battery.

In some embodiments, the system can comprise one or more latches orlocks that allow for removal of the one or more modular components. Forexample, a user may release the one or more latches or locks to allowremoval of the one or more modular components, such as one or more freshor purified water tanks and/or wastewater tanks. After reattachment, theuser may again lock the one or more latches or locks to keep the one ormore modular components in place within the system or device.

In certain embodiments, the amniotic bath incubator system and/or deviceitself can comprise one or more wheels or rollers. For example, a usermay be able to easily or conveniently move the amniotic bath incubatorsystem and/or device itself by using the one or more wheels or rollers.

Synthetic/Simulated Amniotic Fluid

Biological amniotic fluid is the protective liquid bathing the fetusduring pregnancy and serves several functions such as heat reservoir forthermoregulation, a reservoir for absorption of water by the fetusthrough the intramembranous pathway and an environment for fetalmovement and comfort. Source of amniotic fluid is through combination ofexcretions from fetal kidneys, respiratory system, gastrointestinalsystem and surface of the placenta. Amniotic fluid can be said to beunique amongst all physiologic fluids in terms of its osmolality, pH andmineral content.

In some embodiments, a synthetic or simulated amniotic fluid can beproduced to be used in conjunction with the amniotic bath incubatorsystems, devices, and methods. For example, an infant, preterm orotherwise, can be placed in a synthetic or simulated amniotic fluid. Thesynthetic or simulated amniotic fluid can comprise one or morecharacteristics that are similar to those of biological amniotic fluid.For example, the composition of the synthetic or simulated amnioticfluid can comprise one or more electrolytes, minerals, proteins,albumin, amino acids, glucose, enzymes, phospholipids, hormones, lipids,carbohydrates, lactate, and/or pyruvate. In certain embodiments, thesynthetic or simulated amniotic fluid can comprise one or more nutrientsand/or drugs.

In some embodiments, the simulated or synthetic fluid can comprise acrystalloid solution of electrolytes and minerals especially designed tomatch or mimic the osmolality, pH, electrolyte and mineral content ofphysiologic amniotic fluid in the womb. The osmolality, pH, electrolyteand/or mineral content of physiologic amniotic fluid can change from the22nd week to term at 40th week of pregnancy. As such, in certainembodiments, various concentrations of concentrated crystalloidsolutions can be placed into one or more cartridges and/or the amount offluid to be mixed with contents of a cartridge can be adjusted by anoperator through one or more dosing pumps. The simulated amniotic fluidcan be produced in some embodiments through mixing of fluid from aconcentrated electrolyte and mineral cartridge with deionized purifiedwater. The cartridge can be replaced by the nurses every about 6 hours,about 12 hours, about 18 hours, about 24 hours, about 36 hours, about 48hours, and/or within a range defined by two of the aforementionedvalues. In certain embodiments, the cartridge can be replaced after aparticular number of refills of the simulated amniotic fluid, forexample after about 1 refill, about 2 refills, about 3 refills, about 4refills, about 5 refills, about 6 refills, about 7 refills, about 8refills, about 9 refills, about 10 refills, and/or within a rangedefined by two of the aforementioned values.

The synthetic or simulated amniotic fluid can comprise one or more aminoacids and/or glucose. The one or more amino acids and/or glucose can beabsorbed by an infant from the synthetic or simulated amniotic fluidthrough the skin. The potential uptake of such substances can enhanceorgan weights and fetal growth. In some embodiments, the concentrationof one or more amino acids and/or glucose in the synthetic or simulatedamniotic fluid can be higher than the concentration of the one or moreamino acids and/or glucose in physiologic amniotic fluid, for example toprovide a sufficient source of nutrition for the infant.

More specifically, in some embodiments, the synthetic or simulatedamniotic fluid can comprise Na. The concentration of Na in the syntheticor simulated amniotic fluid can be, for example, between about 120 mEQ/land about 150 mEQ/l or between about 130 mEQ/l and about 140 mEQ/l. Incertain embodiments, the Na concentration of the synthetic or simulatedamniotic fluid can be about 136.10 mEQ/l and/or between about 131.95mEQ/l and about 140.25 mEQ/l.

In certain embodiments, the synthetic or simulated amniotic fluid cancomprise K. The concentration of K in the synthetic or simulatedamniotic fluid can be, for example, between about 2 mEQ/l and about 5mEQ/l or between about 3 mEQ/l and about 4.5 mEQ/l. In certainembodiments, the K concentration of the synthetic or simulated amnioticfluid can be about 3.89 mEQ/l and/or between about 3.71 mEQ/l and about4.07 mEQ/l.

In some embodiments, the synthetic or simulated amniotic fluid cancomprise Cl. The concentration of Cl in the synthetic or simulatedamniotic fluid can be, e.g., between about 100 mEQ/l and about 120 mEQ/lor between about 105 mEQ/l and about 115 mEQ/l. In certain embodiments,the Cl concentration of the synthetic or simulated amniotic fluid can beabout 110.30 mEQ/l and/or between about 114.1 mEQ/l and about 106.5mEQ/l.

In certain embodiments, the synthetic or simulated amniotic fluid cancomprise Ca. The concentration of Ca in the synthetic or simulatedamniotic fluid can be, e.g., between about 2.5 mEQ/l and about 4.5 mEQ/lor between about 3 mEQ/l and about 4 mEQ/l. In certain embodiments, theCa concentration of the synthetic or simulated amniotic fluid can beabout 3.39 mEQ/l and/or between about 2.97 mEQ/l and about 3.81 mEQ/l.

In some embodiments, the synthetic or simulated amniotic fluid cancomprise glucose. The concentration of glucose in the synthetic orsimulated amniotic fluid can be, e.g., between about 20 mg/dl and about35 mg/dl or between about 25 mg/dl and about 30 mg/dl. In certainembodiments, the glucose concentration of the synthetic or simulatedamniotic fluid can be about 27.67 mg/dl and/or between about 15.72 mg/dland about 39.62 mg/dl. In certain embodiments, the synthetic orsimulated amniotic fluid can comprise a higher concentration of glucosethan found in physiologic amniotic fluid. For example, the concentrationglucose in the synthetic or simulated amniotic fluid can be above about30.00 mg/dl, about 40.00 mg/dl, about 50 mg/dl, about 60 mg/dl, about 70mg/dl, about 80 mg/dl, and/or between a range defined by two of theaforementioned values.

In certain embodiments, the synthetic or simulated amniotic fluid cancomprise HCO₃. The concentration of HCO₃ in the synthetic or simulatedamniotic fluid can be, e.g., between about 5 mEQ/l and about 25 mEQ/l orbetween about 10 mEQ/l and about 20 mEQ/l. In certain embodiments, theHCO₃ concentration of the synthetic or simulated amniotic fluid can beabout 14.50 mEQ/l and/or between about 12.33 mEQ/l and about 16.67mEQ/l.

In some embodiments, the synthetic or simulated amniotic fluid cancomprise protein. The total concentration of protein in the synthetic orsimulated amniotic fluid can be, e.g., between about 0.1 g/dl and about1.0 g/dl or between about 0.2 g/dl and about 0.8 g/dl. In certainembodiments, the total protein concentration of the synthetic orsimulated amniotic fluid can be about 0.55 g/dl and/or between about0.36 g/dl and about 0.74 g/dl. In certain embodiments, the totalconcentration of protein in the synthetic or simulated amniotic fluidcan be above about 0.1 g/dl, about 0.2 g/dl, about 0.3 g/dl, about 0.4g/dl, about 0.5 g/dl, about 0.6 g/dl, about 0.7 g/dl, about 0.8 g/dl,about 0.9 g/dl, about 1.0 g/dl, about 1.1 g/dl, about 1.2 g/dl, about1.3 g/dl, about 1.4 g/dl, about 1.5 g/dl, about 1.6 g/dl, about 1.7g/dl, about 1.8 g/dl, about 1.9 g/dl, and/or about 2.0 g/dl. In someembodiments, the total concentration of protein in the synthetic orsimulated amniotic fluid can be higher than the total concentration ofprotein in physiologic amniotic fluid.

In certain embodiments, the synthetic or simulated amniotic fluid cancomprise albumin. The concentration of albumin in the synthetic orsimulated amniotic fluid can be, e.g., between about 0.1 g/dl and about1.0 g/dl or between about 0.2 g/dl and about 0.7 g/dl. In certainembodiments, the albumin concentration of the synthetic or simulatedamniotic fluid can be about 0.42 g/dl and/or between about 0.31 g/dl andabout 0.53 g/dl. In some embodiments, the albumin concentration of thesynthetic or simulated amniotic fluid can be above about 0.1 g/dl, about0.2 g/dl, about 0.3 g/dl, about 0.4 g/dl, about 0.5 g/dl, about 0.6g/dl, about 0.7 g/dl, about 0.8 g/dl, about 0.9 g/dl, and/or about 1.0g/dl. In certain embodiments, the albumin concentration of the syntheticor simulated amniotic fluid can be higher than the albumin concentrationof physiologic amniotic fluid.

In some embodiments, the osmolality of the synthetic or simulatedamniotic fluid can be, e.g., between about 200 mosm/kg and about 350mosm/kg or between about 250 mosm/kg and about 300 mosm/kg. In certainembodiments, the osmolality of the synthetic or simulated amniotic fluidcan be about 272.50 mosm/kg and/or between about 264.52 mosm/kg andabout 280.48 mosm/kg.

In certain embodiments, the pH of the synthetic or simulated amnioticfluid can be between about 7 and about 10 or between about 8 and about9. In certain embodiments, the pH of the synthetic or simulated amnioticfluid can be about 8.4 and/or between about 8.01 and about 8.79.

Synthetic/Simulated Amniotic Fluid Production

To produce the synthetic or simulated amniotic fluid, in someembodiments, one or more components of the synthetic or simulatedamniotic fluid can be dissolved in purified or fresh water. For example,one or more cartridges comprising one or more components of thesynthetic or simulated amniotic fluid in concentrated doses can bedissolved in purified or fresh water to produce the synthetic orsimulated amniotic fluid for use in the bath. In some embodiments, thesystem can comprise a single cartridge that comprises all of the desiredcomponents of the synthetic or simulated amniotic fluid. In otherembodiments, the system can comprise a plurality of cartridges that eachcomprises some subset of the desired components of the synthetic orsimulated amniotic fluid. For example, in some embodiments, a firstcartridge can comprise a crystalloid solution of one or moreelectrolytes and/or minerals. The first cartridge can also comprisealbumin. In certain embodiments, the system can comprise a secondcartridge that comprises one or more amino acids and/or glucose. Thecontents of the second cartridge can be dissolved after, before, and/orsimultaneously with the contents of the first cartridge. In certainembodiments, the system can comprise three, four, five, six, seven,eight, nine, and/or ten cartridges, each comprising differentcompositions. For example, each of the plurality of cartridges cancomprise different components of the synthetic amniotic fluid and/ordifferent concentrations thereof and/or different compositions thereof.

In some embodiments, the system can comprise a plurality of cartridgesfor use with infants in different stages of development, age, size, orthe like. For instance, a particular cartridge may be optimized forproducing an amniotic bath for infants at a particular stage of growth.In some embodiments, the plurality of cartridges may all comprise thesame or similar components but at different concentrations. In certainembodiments, the plurality of cartridges may each comprise differentcompositions of components and/or different concentrations. Theplurality, of cartridges and their compositions and concentrations canbe designed to match or mimic the composition of biological amnioticfluid depending on the development of pregnancy. As such, theconcentration and/or dose of each component of the simulated and/orsynthetic amniotic fluid can be changed as the infant develops. In someembodiments, the concentration of one or more electrolytes, minerals,amino acids, albumin, vitamins, glucose, and/or medicines or othertherapeutic agents in the synthetic amniotic fluid can be controlledautomatically, semi-automatically, or manually through a control unit.The control unit can be configured to adjust the injection rate of adosing pump configured to pump purified water and/or contents of acartridge for mixing to control the concentration of one or morecomponents. The concentration of one or more components of the syntheticamniotic fluid can be controlled according to gestation age of theinfant, size of the infant, and/or other medical indications.

In some embodiments, one or more desired components are dissolved infresh or purified water directly in the amniotic bath incubator systemor device. In other embodiments, the one or more desired components aredissolved in fresh or purified water outside of the amniotic bathincubator system or device and are added to the device or systemafterwards. In certain embodiments, one or more desired components aredissolved in fresh or purified water to produce the synthetic orsimulated amniotic fluid in a batch process. In other embodiments, oneor more desired components are dissolved in fresh or purified water toproduce the synthetic or simulated amniotic fluid via continuous mixing.For example, the amniotic bath incubator system or device can compriseone or more metered or dosing pumps that are configured to pump aparticular amount of purified or fresh water and/or concentratedsynthetic amniotic fluid or components thereof to continuously mix andobtain the synthetic or simulated amniotic fluid.

More specifically, in certain embodiments, one or more dosing or meteredpumps of the system can be configured to precisely mix a desired amountof concentrated amniotic fluid with filtered or purified fresh water tocreate the right balance of pH and osmolality required by the clinicianfor each particular gestational age. The simulated amniotic fluid canthen be pumped into the bath. In some embodiments, the simulatedamniotic fluid is pumped into the bath after a disinfection process, forexample through a UV bacterial filter.

The simulated or synthetic amniotic fluid of the bath can be drained orflushed and replaced periodically and/or continuously to reduce risks ofcolonization with bacteria. For example, the bath fluid can be drainedand replaced continuously, every about 3 hours, about 6 hours, about 9hours, about 12 hours, about 15 hours, about 18 hours, about 21 hours,about 24 hours, about 36 hours, about 48 hours, and/or within a rangedefined by two of the aforementioned values. In some embodiments, thebath fluid can be drained and replaced with every infant stool. In someembodiments, the system can comprise a rinser on the unit configured toallow rinsing of the skin of the infant from solids and for hydration ofhead and neck area by the parents and staff.

In some embodiments, the amniotic bath incubator can comprise one ormore sensor to measure or estimate the volume of synthetic or simulatedamniotic fluid present in the bath. For example, the amniotic bath cancomprise one or more weight sensors configured to weigh and monitor aweight of the bath. Similarly, the amniotic bath can comprise one ormore fluid level sensors configured to detect the fluid level within thebath. In certain embodiments, the amniotic bath incubator can compriseone or more sensors for determining a volume of amniotic fluid fed tothe bath and a volume of fluid exiting the bath, for example fromoverflowing and/or through a disposal line.

In certain embodiments, the system can be configured to produced and/orprovide additional volume of synthetic or simulated amniotic bath fluidto the bath based on the measured or estimated volume of synthetic orsimulated amniotic fluid present in the bath. For example, the systemcan be configured to newly produce additional synthetic or simulatedamniotic bath fluid or provide pre-produced synthetic or simulatedamniotic bath fluid to the bath of an amount or volume necessary tomaintain a steady or full level of fluid within the bath.

Disinfection

In some embodiments, the synthetic or simulated amniotic fluid can bedisinfected before placing an infant in the synthetic or simulatedamniotic fluid. For example, in certain embodiments, a disinfectioncartridge comprising one or more disinfecting agents, chemical orotherwise, can be configured to be dissolved in purified water and/orsynthetic or simulated amniotic fluid. In other embodiments, thepurified water and/or synthetic or simulated amniotic fluid can bepumped through a disinfection process within or outside of the amnioticbath incubator system or device.

In some embodiments, the purified or fresh water can be disinfectedbefore dissolving one or more components for producing the synthetic orsimulated amniotic fluid. In other embodiments, synthetic or simulatedamniotic fluid that has already been produced is subsequentlydisinfected. In certain embodiments, disinfection and dissolution ofcomponents for producing the synthetic or simulated amniotic fluid areperformed simultaneously in purified or fresh water.

In certain embodiments, a disinfection procedure of the whole or part ofthe amniotic bath incubator system or device can be performed. Forexample, disinfection fluid can be passed through one or more tubes,tanks, or the like of an amniotic bath incubator to disinfect thesystem. A disinfection procedure can be performed manually and/orautomatically. The disinfection procedure can be performed periodically.For example, the disinfection procedure can be performed about or atleast about once every about 12 hours, about 24 hours, about 36 hours,about 48 hours, about 60 hours, about 72 hours, about 4 days, about 5days, about 6 days, about 7 days, about 2 weeks, about 3 weeks, about 4weeks, and/or within a range defined by two of the aforementionedvalues.

Method of Use Overview

Referring to FIGS. 2-11, in some embodiments, with the reservoir 16filled, the filling tube 84 may be placed in the hose bin 90 for futureuse. The user may then open the amniotic container port 86 and insert afresh amniotic fluid supply 88. An expended amniotic fluid supply 88 maybe removed as necessary. The amniotic fluid supply 88 can be presseddown on the valve 92. The reservoir 16 can be then reinserted into theframe 14, thereby reconnecting the power supply 98, water bib 106 andamniotic fluid bib 108.

With the reservoir 16 reconnected, the power supply 98 can cause thevalve 92 to open, causing concentrated synthetic amniotic fluid 94 toenter the filter 100, pump 102, and valve system 104, thereby mixing apredetermined amount of concentrated synthetic amniotic fluid 94 withfluid in the reservoir 16. While the reservoir 16 is connected to thepower supply 98, the heating element 96 can pre-heat the fluid andamniotic fluid supply 88 to a preferred predetermined temperature,thereby easing the amount of heating required at the bath 12. With thereservoir 16 filled and at the proper temperature, the incubator 10 canbe ready to receive an infant.

The user can remove the dome 22 and insert a cover 62 in the bath 12.The bath 12 can be then filled with a desired amount of syntheticamniotic fluid 12 using the amniotic fluid control 54. Optionally, watermay be added using the water control 52, if only water is desired, or ifa weaker concentration of synthetic amniotic fluid 94 is needed. Theadditional controls 56 can be used to control temperature, and othercharacteristics of the bath 12. The temperature, liquid composition, andother data can be optionally visible on a sensor readout 60 located onthe lower sensor panel 66. The temperature of fluid in the bath 12 canbe maintained by heating elements proximal to the bath 12. If necessary,the sliding shelf 28 may be extended for holding the infant or othermaterials.

The infant can be placed in a semi-seated position in the sump portion40 of the bath 12, supported against the seatback 34 with the infant'slegs against the post 36. The infant may also be fastened with safetystraps. The surface features 38 can help stimulate the infant's skin andprevent undesired adhesion to the cover 62. Once the infant is locatedin the bath 12, and surrounded by synthetic amniotic fluid 94 at apreferred temperature, the dome 22 may be replaced to help maintaintemperature and sterility. To access the infant without removing thedome 22, a user can reach through one or more sleeve ports 24 in someembodiments. In another embodiment, the infant can be completelysubmerged if adequate nutrition and oxygenation is maintained throughumbilical vessels by medical staff and strict sterile environment of thefluid maintained in medical setting to allow swallowing action ofamniotic fluid and diaphragm exercise of fluid filled lungs similar tofetal action in mother's womb.

In certain embodiments, for a more sterile embodiment, one or moresleeves may be provided in the one or more sleeve ports 24. In someembodiments, a radiant heating lamp can be provided on the device toprovide necessary heat during examinations and procedures performed bythe physicians or nursing staff, when the synthetic amniotic fluid 94level is decreased or drained from the bath 12, when the cover 62 ischanged, and/or when refreshing the fluid with the infant still in placein the bath 12. As discussed, sterile and fluid resistant leads,catheters, tubing and other elements may be included which attach to theinfant's body while submerged in synthetic amniotic fluid, or attachedto the infant's face or head above the fluid. These may be coupled tovarious medical and monitoring devices in the ICU.

Any synthetic amniotic fluid 94 splashing out of the sump portion 40 canremain on the shallow portion 42 of the bath 12, confined by the raisedrim 44. In the event the shallow portion 42 is overfilled, excess fluidtraveling over the raised rim 44 can drain into the gutter 46 and alsodrain down into the primary tank 18. A conforming drain region 64surrounding the sump portion 40 can also drain down into the primarytank 18.

The infant may remain in the bath 12 for a predetermined period of time,and/or until the synthetic amniotic fluid 94 becomes contaminated. Inparticular, the cover 62 can be exchanged routinely in a scheduledmanner to prevent bacterial or fungal growth. When the fluid requireschanging, the infant can be removed, and the contaminated amniotic fluid132 can be drained from the bath 12 using a central drain at the base ofthe sump portion 40. Contaminated amniotic fluid 132 leaving the bath 12can enter the wastewater inlet 114 of the primary tank 18, which canbegin to fill and move into the wastewater spout 116. Once thecontaminated amniotic fluid 132 reaches the top of the wastewater spout116, it can drain into the secondary tank 20. The primary tank 18 andsecondary tank 20 can be of sufficient volume, such that a largequantity of contaminated amniotic fluid 132 can be washed through thebath 12 before they need to be emptied.

Eventually, the secondary tank 20 may fill enough to warrant emptying.To remove the secondary tank 20, the user may first seal the wastewatervalve 118 on the primary tank 18, preventing contaminated amniotic fluid132 from escaping when the secondary tank 20 is removed. The user canthen depresses the wastewater release pedal 70, and rolls out thesecondary tank 20 along the guides 32, and rolls it to a desireddrainage site, such as a utility sink or similar cleaning location. Bylifting the first secondary tank handle 122, the secondary tank 20 canbe balanced for raising it into a pouring position. The second secondarytank handle 124 can then be lifted to pour contaminated amniotic fluid132 out of the emptying spout 134. Cleaning water or solution may beintroduced into the secondary tank 20 for sterilization.

While the secondary tank 20 is being emptied, the primary tank 18 can beleft in place to accept contaminated amniotic fluid 132 from the bath12. When the secondary tank 20 is placed back in position, thewastewater valve 118 can be opened allowing excess contaminated amnioticfluid 132 to flow from the primary tank 18 into the secondary tank 20.In some embodiments, the primary tank 18 can be removed for emptying andcleaning while leaving the secondary tank 20 in position. After theprimary tank 18 is cleaned, it can be placed back atop the secondarytank 20. A registration point 128 on the secondary tank 20 can match acomplimentary registration point 130 on the primary tank 18 to make surethey are in proper alignment, and that the wastewater inlet 114 isaligned with the bath 12 before contaminated amniotic fluid 132 isdrained into them.

System Overview

FIG. 12 is a block diagram depicting an overview of an embodiment of anamniotic bath incubator system for premature infants. As depicted inFIG. 12, in some embodiments, an amniotic bath incubator systemcomprises a user interface 1202, a control unit 1204, a bath 1206, awaste water system 1208, and/or an amniotic fluid preparation system1210.

The fluid preparation system 1210 can be configured to intake freshand/or purified water from a fresh water intake 1212. In someembodiments, a water tank, which itself can be disposable, is configuredto hold the fresh water. The water tank can be manually and/orautomatically filled when determined to be completely or partiallyempty. In certain embodiments, the filling of the water tank can becontrolled via one or more sensors, values, control units, power sourcessuch as a battery source and/or a simple HMI interface.

In some embodiments, the water provided to the fluid preparation systemis purified and/or heated. The purification and/or heating of the watercan be performed within the fluid preparation system 1210 and/or beforebeing provided to the fluid preparation system 1210. For example, thewater can be heated to about 36.7° C. or about 37° C. In certainembodiments, the water can be re-circulated through a heating systemdepending on the initial water temperature to reach a targettemperature. The purified and/or heated water can be mixed with apremixed concentrated fluid comprising one or more components of thesynthetic or simulated amniotic fluid. For example, in some embodiments,the premixed concentrated fluid can be provided in the form of one ormore cartridges. The contents of the premixed concentrated fluid canmixed in the purified and/or heated water via a metering pump to form anamniotic bath fluid.

The amniotic bath 1206 can be configured to be filled with synthetic orsimulated amniotic fluid. The level and/or temperature of the bath fluidcan be monitored during and/or after a filling process of the bath. Incertain embodiments, after filling, a heater located adjacent to thebath can be configured to maintain a desired fluid temperature. Forexample, in certain embodiments, the bath can comprise and/or beconfigured to be used in conjunction one or more temperature sensorsand/or a thermostat feedback mechanism. The bath can be maintained at atemperature of about 37° C. In certain embodiments, the operator canadjust the temperature of the bath lower than about 37° C., for examplein case of hyperthermia and/or risk of hyperthermia. As an example, thetemperature of the bath can be set at about 36.5° C., about 36° C.,about 35.5° C., about 35.0° C. and/or even lower levels, such as about30° C., about 25° C., and/or about 20° C. if induced hypothermia isdesired medically. In contrast, the operator can adjust the temperatureof the bath above about 37° C., for example in case of hypothermiaand/or risk of hypothermia. As an example, the temperature of the bathcan be set at about 37.5° C., about 38° C., about 38.5° C., about 39.0°C. and/or even higher levels, such as about 40° C., about 41° C., and/orabout 42° C. if induced hyperthermia is desired medically.

In certain embodiments, a temperature sensor can also be placed on theinfant, for example on the scalp to monitor human body temperature. Themonitored human body temperature can be utilized in a feedback mechanismand be transmitted to the main unit for alarms in case of bodytemperature fluctuations.

Further, in certain embodiments, the water level of the bath can becontinuously, constantly, and/or periodically monitored to ensure thatthe infant is not completely submerged in the bath. In certainembodiments, the system comprises one or more safety harness mechanismsbuilt into the cover to protect infant from accidental submersion. Also,in some embodiments, one or more fluid sensors can be configured to beplaced near the infant's head to determine and alarm a user if fluid isdetected. For example, in certain embodiments, the one or more fluidsensors can be worn around the infant's neck in the form of a necklace.

In certain embodiments, when the system determines that the water levelis above a predetermined level and/or the infant is submerged in thefluid or about to, for example from the one or more fluid sensors ordetected failure of the harness system, the system can be configured tosound or display an alarm to a nurse and/or automatically drain the bathfluid completely or partially.

In some embodiments, excess and/or undesired fluid from the fluidpreparation and/or bath can be drained with drain lines into awastewater tank 1208. In certain embodiments, the wastewater tank 1208can be directly or indirectly connected to a sewer line for wastewaterdisposal 1214, for example through a flushing mechanism. In someembodiments, the wastewater tank 1208 can be disconnected from thesystem and main assembly for content disposal. For example, thewastewater tank 1208 can be rolled to a nearby wastewater drain by thestaff. For draining the wastewater, a pump and control unit with simpleHMI interface can be used with power through a rechargeable battery incertain embodiments.

Fluid Preparation Subsystem

FIG. 13 is a block diagram depicting an embodiment of a fluidpreparation sub-system of an amniotic bath incubator system forpremature infants. In some embodiments, a fluid preparation subsystem1306 comprises one or more fresh water tanks 1A. The fresh water tank 1Acan comprise a disposable and/or replaceable cover. The cover can besterile in some embodiments. In certain embodiments, the fresh watertank 1A is configured to be filled with a hose attached to faucet withslip-on fitting 9A. The fresh water tank 1A can be configured to bedirectly and/or indirectly connected to a water supply. In certainembodiments, the fresh water tank 1A can be non-disposable and/ornon-replaceable. The fresh water tank 1A can be configured to bedisinfected along with other non-disposable and/or non-replaceablecomponents of the system that are in contact with water, syntheticamniotic fluid, cartridge fluid, and/or patient or infant.

In certain embodiments, one or more water level sensors 3A, 4A, and 5Acan be provided in a fluid preparation subsystem 1306. The one or morewater level sensors 3A, 4A, and 5A can be configured to measure thewater level in the tank during a fill process.

In some embodiments, during a tank fill, the fluid preparation subsystem1306 is detached from the main system. In certain embodiments, the fluidpreparation subsystem 1306 does not need to be detached from the mainsystem during a tank fill. The fluid preparation subsystem 1306 cancomprise one or more power supplies, such as a rechargeable battery 2A.

In some embodiments, one or more level sensors 4A of the fluidpreparation subsystem 1306 are configured to trigger an alarm that thefaucet needs to be closed when the tank 1A is full or is near full. Incertain embodiments, a water supply is automatically closed when one ormore level sensors 4A of the fluid preparation subsystem 1306 detectthat the tank 1A is full, near full, and/or at, above, and/or below apredetermined level.

In certain embodiments, if the water level continues to rise above thecapacity of the fresh water tank 1A, for example either because anoperator or nurse does not close the faucet valve or if the system failsto automatically close the faucet valve, overflow positioned on the topof fresh water tank 1A can discharge additional water from the tankthrough one or more drain openings 3A out of the system.

In some embodiments, a system disinfection process can be performedperiodically and/or continuously. For example, in certain embodiments,system disinfection is performed continuously by allowing disinfectionfluid to continuously pass through the system. In some embodiments,system disinfection is performed periodically by allowing disinfectionfluid to pass through the system or portions thereof at certain periods,for example when the patient or infant is placed out of the amnioticincubator. Periodic system disinfection can be performed periodicallyaccording to a predetermined schedule and/or as needed or convenient,for example when the infant or patient is placed out of the amnioticincubator.

In some embodiments, system disinfection can be performed by inserting acartridge with concentrated disinfection fluid. For example, adisinfection cartridge 3A may be placed instead of a concentratedamniotic bath fluid cartridge. The contents of the disinfectioncartridge 3A can be dissolved in the water and allowed to pass throughthe system. For example, fresh water can be pumped by one or more pumps11A via a bypass valve 13A and further into a water heating system 14A.In some embodiments, a disinfection cartridge 3A and one or moreamniotic bath fluid cartridges can be color coded using different colorsand/or other markings for differentiation between the two. As such, insome embodiments, an operator or nurse can visually notice and/ordetermine that a correct cartridge has been installed. In certainembodiments, the disinfection can be colored, for example red, orange,yellow, blue, purple, or the like. As such, in certain embodiments, anoperator or nurse can easily and/or immediately determine visually ifdisinfection fluid, or a small amount of disinfection fluid, reaches theamniotic bath while the patient or infant is placed in the bath. In someembodiments, the disinfection cartridge can comprise a shape that isdifferent from that of an amniotic bath fluid cartridge. For example,the disinfection cartridge can comprise a small bump-tab that can beconfigured to trigger an electro-mechanical sensor. Theelectro-mechanical sensor, once triggered, can be configured to transmita signal to a control unit that a disinfection cartridge has beeninstalled. In some embodiments, the control unit can be configured toprevent filling of the amniotic bath until all pre-requirements, such asdisinfection, are fulfilled. In certain embodiments, after thedisinfection procedure is completed, the system can be washed fromremnants of disinfection fluid by being washed by fresh, heated, and/orunheated water through all or a portion of the components of the systemthat were in contact with the disinfection fluid.

In certain embodiments, the system comprises one or more metering ordosing pumps 9A to add a controlled amount of concentrated disinfectionfluid to the water line to allow for controlled continuous mixing. Insome embodiments, concentrated disinfection fluid can be dissolved via abatch process.

The mixed disinfection fluid can be returned to the fresh water tank 1Athrough one or more valves 17A to disinfect the water tank 1A. Forexample, the mixed disinfection fluid can pass through a return linethrough one or more connected slip on fittings 20A, 22A. Other portionsof the system can be disinfected by pumping the mixed disinfection fluidfrom fresh water tank 1A making necessary loops to reach all or one ormore tubes, fitting and equipment in contact with bath fluid and water.After the disinfection process, remaining fluid can be drained from thesystem through one or more valves 7A, 15A, 16A, 117A, 119A and 120A intothe wastewater tank 203A and the fresh water tank 1A can be disposed.The one or more slip-on fittings 20A, 22A can be configured to beconnected only during the disinfection process.

Amniotic Bath Subsystem

FIG. 14 is a block diagram depicting an embodiment of a bath sub-systemof an amniotic bath incubator system for premature infants.

In some embodiments, the amniotic bath may be changed periodically orcontinuously. To do so, an operator may initiate bath fluid change usinga user interface 1202. In some embodiments, water from a fresh watertank 1A can flow through a strainer 6A to remove large impurities. Oneor more pumps 10A of the fluid preparation subsystem can be configuredto pump water through a water purification system 12A which can removeorganic and nonorganic impurities. In some embodiments, the waterpurification system 12A can be external from the amniotic bath incubatorsystem and/or serve as constant water supply. In such embodiments, afresh water tank 1A may or may not be used. In some embodiments, acentral water purification system may serve as constant water supply.Also, in such embodiments, the fresh water tank 1A may or may not beused.

After the water purification process, water can be pumped through aheating system 14A, which can be configured to heat the water to arequired temperature, such as about 37 C. In some embodiments, ametering pump 9A can add premixed fluid from one or more amniotic fluidcartridges 3A to water. The mixing can be performed in a batch processin some embodiments. In certain embodiments, in-pipe mixing occurs toform the amniotic bath fluid. In some embodiments internal, an externalor central water purification system may supply preheated water. In suchembodiments, a heating system 14A may or may not be used to heat waterto a required or predetermined temperature, depending on the outputtemperature of the water purification system. In some embodiments, oneor more temperature sensors can be provided to detect the temperature ofthe purified water. The heating system 14A can be automaticallycontrolled to heat the water to a required or predetermined temperaturebased on the detected current temperature.

The pre-mixed fluid in the cartridge 3A can comprise one or moreelectrolytes, minerals, pharmaceuticals, proteins, peptides, lipids,lactate, pyruvate, enzymes, hormones, antibodies, amniotic stem cellsand/or other cellular material. In certain embodiments, one or morepharmaceuticals or other desired compounds can also be added to theamniotic bath fluid, for example manually and/or through the same and/oradditional cartridge comprising such components. More specifically, insome embodiments, a single cartridge can comprise one or more of any ofthe synthetic amniotic fluid components discussed herein, for example atconcentrated levels. In other embodiments, a plurality of cartridges,for example 2, 3, 4, 5, 6, 7, 8, 9, or 10 cartridges, can comprise oneor more of the synthetic amniotic fluid components discussed herein.

Mixing proportions for the amniotic bath fluid can be determined by aflow rate measurement of the fresh water by one or more flow meters.21A. The mixed amniotic bath fluid can reach a manifold 112, in someembodiments, after passing through one or more valves 17A and/or beingsterilized by one or more UV sterilizing units 113A.

In some embodiments, the fluid temperature can be measured with one ormore temperature sensors 116A. If temperature is not adequate, forexample below 37° C., the manifold 112A can be drained via one or morevalves 117A. In case of the failure of the temperature control system,an anti-scald valve 107 can be provided to prevent fluid from reachingthe bath. In case of overpressure, for example if the temperature is toohigh and the one or more drain valves 117A fails to open, one or moresafety valves 110A can be provided in the system. The one or more safetyvalves 110A may open to release the fluid into a drain line. In certainembodiments, a flow switch 114A can be configured to trigger an alarmindicating that the one or more safety valves have moved to an openposition.

When the fluid temperature, as measured by the one or more temperaturesensors 116A, is at required level, such as at 37° C., one or morevalves 106A may open to allow the amniotic bath fluid to flow into thebath. In contrast, when fluid temperature, as detected by the one ormore temperature sensors 116A, is outside of a certain predeterminedrange, such as outside of a range between about 35° C. to about 39° C.or outside of a range between about 36° C. to about 38° C., the one ormore valves 106A can be configured to automatically close, therebypreventing the amniotic bath fluid from flowing into the bath. Incertain embodiments, the fluid is configured to flow into the baththrough one or more filters 115A and/or divergent nozzles 121A.Divergent nozzles can be used to prevent splashing and thereby allowingrapid filling of the bath with the synthetic or simulated amnioticfluid, for example at rates between about 0.1 liters/sec to about 0.2liters/sec. In certain embodiments, one or more divergent nozzle checkvalves may be installed to prevent backflow from the bath into thetubing system. In some embodiments, the one or more divergent nozzlescan be disposable. In certain embodiments, a hose attaching the one ormore divergent nozzles to the tubing system or manifold can comprise aspecial fitting, configured to open a safety check valve attached to thesystem when the fitting is attached to the tubing system. The safetycheck valve can be configured to prevent outflow of the fluid from thetubing system in case a divergent nozzle is not installed and/or is notproperly secured to the tubing system with the special fitting.

In certain embodiments, if the fresh water tank 1A does not have enoughwater to allow for an amniotic fluid bath change, the system can beconfigured to trigger an alarm to prevent the bath change until thefresh water tank 1A is refilled. If one or more sensors 8A detect thatone or more cartridges are empty, the system can also be configured totrigger an alarm to prevent bath change until the one or more cartridgesare replaced. Once the bath is refilled, one or more drain valves 7A,15A, 16A, 120A can be configured to be opened to drain the tubing fromany remaining bath fluid or water.

In some embodiments, the amniotic bath subsystem 1304 comprises arinsing system for rinsing an infant. In certain embodiments, a rinsingsystem 111A is supplied with the bath fluid through a manifold 112A in asimilar manner as the bath. If the user desires to use the rinsingsystem 111A, in some embodiments, the user can select a rinsing optionfrom a user interface, such as an HID interface. In some embodiments,one or more temperature sensors 116A can be configured to detect thetemperature of the fluid. In certain embodiments, if the temperature ofthe fluid is at a desired temperature, such as 37° C. for example, oneor more valves 109 can be configured to open and a hose can supply therinsing system 111A with the bath fluid. If the detected temperature istoo high, such as above 37° C., an anti-scald valve 108A can beconfigured to close, thereby preventing the fluid from flowing to therinsing system 111A. In some embodiments, a rinser can comprise atrigger device, which can be connected to a shut-off valve. For example,in certain embodiments, a user or operator may have to push the triggerin order to open a valve when holding the rinser handle to preventaccidental splashing of the patient/infant and/or equipment.

In some embodiments, the amniotic bath incubator system or device oramniotic bath subsystem thereof comprises a cover or liner configured tobe placed over the bath when emptied. The cover or liner can be sterileand/or disposable for infection control. The cover or liner can alsocomprise a safety harness built onto the cover to prevent accidentalsubmersion of the infant. The cover or liner is not disposable incertain embodiments. The cover or liner, whether disposable ornon-disposable, can comprise a variety of shapes and/or sizes to fit avariety of infants and/or patients.

The amniotic bath can be ergonomically designed to allow anatomic fetalpositioning of the infant with its neck and head above the water level.In some embodiments, slip-on and/or sterile plastic covers can be usedto protect an umbilical catheter(s) and/or other peripheral or centrallines from exposure to the bath water. Anchors can be provided and/orbuilt above the water level to hold the umbilicus above the water levelto prevent exposure of a catheter line(s) to fluid. Anchors and/orumbilical catheter bridges can also be built above the face of theinfant to hold one or more catheters, leads, wires, and/or tubings inplace and to prevent accidental kinking. Cardiac leads 122A, oximeter,and/or skin temperature sensors can be placed on the infant neck and/orscalp to prevent exposure to the bath fluid. In some embodiments a cap,hat, or helmet can be configured to be placed on the patient or infant'shead. The cap, hat, or helmet can be configured to incorporate one ormore or all instruments, sensors, and/or equipment into a single unitthat can be secured on the head of the infant or patient.

In some embodiments, the system can comprise one or more valves 23A,126A for water and/or bath fluid sampling. For example, one or morevalves 23A, 126A can be used to sample the water and/or bath fluidperiodically to check the contents and/or temperatures thereof.

In certain embodiments, sterile techniques, gloves and/or equipment canbe used when infant manipulation or contact is necessary. Further, earand/or eye safety devices can be placed on the infant to minimizeexposure to loud noises and/or lights. In certain embodiments, anadditional cover(s) for the bath may be used to create a dark and quietenvironment for the infant. In some embodiments the cap, hat, or helmetcan be configured to incorporate eye and/or ear protection elements intoa single unit that can be secured on the head of the infant or patient.

In some embodiments, the temperature of the bath fluid in the bath canbe measured by one or more temperature sensors 102A, 104A. Further, incertain embodiments, the temperature of the bath fluid in the bath canbe maintained at a desired temperature, such as 37° C., by one or moreheaters 101A. In normal operation, the level of the bath can becontrolled by a manual, semi-automated, or automated level regulator119A. In certain embodiments, one or more additional temperature sensors124A can be placed on the infant skin to measure body temperature. Insome embodiments, the cap, hat, or helmet can comprise one or moretemperature sensors for measuring the body temperature of the infant orpatient. Further, one or more alarms can be configured to be activatedin case of hyperthermia or hypothermia of the infant based on thedetected body temperature.

In some embodiments, it can be advantageous to determine the weight ofthe infant periodically, for example on-demand, and/or continuously. Assuch, in certain embodiments, weight of the infant can be measured usinga load cells unit system 125A, for example with three or more supportpoints. A weight measurement system can be configured to measure theinfant's weight, for example by subtracting known weights of theincubator elements and fluids inside the bath from the total weightmeasured. In certain embodiments, one or more solenoid actuators can beconfigured to make very slight movements of about 1-2 mm or 0.04-0.08inches in order to transfer the weight of the measured elements andinfant from the incubator support to load cells. After the weightmeasurement process is completed, solenoid actuators can be configuredto return to their initial position, transferring weight back to theincubator support. In some embodiments, the weight measurement procedureof the infant can comprise removing the infant from the incubator,resetting or zeroing the weight system, and returning the infant formeasurement.

It can be critical to ensure that the infant is not submerged in theamniotic bath fluid. Accordingly, in some embodiments, a fluid detectoris provided in the form of a necklace sensor 103A to be worn by theinfant. In some embodiments, in case that a critical level in the bathis reached and the necklace sensor 103A is immersed, an alarm can betriggered and/or automatic draining of the bath can be conducted byopening one or more valves 120A. In case the temperature of the bath isabove a desired temperature, such as 37° C., an alarm can also betriggered and/or automatic draining of the bath can be conducted byopening one or more valves 120A. In case the temperature of the bathdrops below a desired temperature, such as 37° C., an alarm can also betriggered and/or automatic draining of the bath can be conducted byopening one or more valves 120A. In certain embodiments, in both casesof abnormal temperature, a bath fluid change procedure can be partlyinitiated automatically and can halt after heating the bath fluid to adesired temperature and/or wait for operator confirmation to continuethrough mixing and/or fluid delivery to the bath. In some embodiments,an adapter can be used to position an infant in a manner that its headand/or mouth/nose are always above the maximum level of the amnioticbath fluid. In such embodiments, the bath can be filled to its maximumlevel, while the position of the infant can be changed depending on aselected adapter. In certain embodiments, the adapter can be positionedin the bath and covered with the disposable cover, to provide adequatetreatment of smaller sized infants.

Wastewater Tank Subsystem

FIG. 15 is a block diagram depicting an embodiment of a wastewatersub-system of an amniotic bath incubator system for premature infants.All wastewater from the fluid preparation and/or bath subsystems can becollected in a wastewater tank 203A. A determined high and/or low levelof fluid in the wastewater tank can be measured by one or more sensors205A. In some embodiments, if the wastewater tank is full, an alarm canbe triggered to prevent change of the bath fluid until the contents ofthe wastewater tank 203A are discharged. When discharging, thewastewater subsystem can be detached from the rest of the system in someembodiments. In certain embodiments, the wastewater tank 203A can bedirectly connected to a sewage line and it may not be necessary todetach the wastewater subsystem from the rest of the system fordischarging. In such embodiments, a check valve may prevent backflowfrom the sewage line to the amniotic bath incubator system. The checkvalve can be configured to be opened by pressure produced by one or morewastewater pumps while discharging.

The wastewater subsystem can comprise a power supply, such as arechargeable battery 208A. The wastewater can be discharged from thetank by one or more pumps 206A. In certain embodiments, one or morelevel sensors 204A can be configured to measure a lower level of thetank. When it is detected that the tank is empty, an alarm can betriggered and/or the control unit 202A can halt the pump. In certainembodiments, the wastewater tank 203 comprises an overflow line in caseof failure of the control and/or measuring system. In some embodiments,a check valve can be configured to prevent backflow from the sewage lineto the amniotic bath incubator system.

Heating Subsystem

In some embodiments, the amniotic bath incubator system can comprise oneor more heating subsystems of one or more varieties. FIG. 16 is a blockdiagram depicting an embodiment of a water heating sub-system of anamniotic bath incubator system for premature infants. As shown in FIG.16, in some embodiments, the system comprises one or more DC watersheaters and/or heated and unheated water can be mixed in the fresh watertank.

More specifically, one or more control valves 14.1 can be configured toopen and supply a DC heater 14.2 and/or an AC heater, with fresh water.The water level in the heater can be controlled by one or more levelsensors 14.10. In some embodiments, when a desired water level isreached, one or more valves 14.1 can be configured to close. In certainembodiments, when the water is heated to a desired temperature, one ormore valves 14.4 can be configured to open and/or discharge water fromthe heater 14.2.

In some embodiments, the heated water can be configured to partiallyfill the tank 14.3. The rest of the volume of the tank can be suppliedfrom an unheated water supply, by opening one or more valves 14.1 andfilling the tank 14.3 where mixing of the heated and unheated water canoccur. The level and/or temperature of the water in the tank 14.3 can bemeasured by one or more sensors 14.9, 14.10. In certain embodiments,when a targeted temperature, such as 37° C., is reached, a control valve14.1 can be configured to close and/or one or more pumps 14.5 can beconfigured to pump the heated water into the system

FIG. 17 is a block diagram depicting an embodiment of a water heatingsub-system of an amniotic bath incubator system for premature infants.As shown in FIG. 17, in some embodiments, the system comprises one ormore AC or DC waters heaters but does not comprise mixing of heated andunheated water in the fresh water tank.

In some embodiments, one or more heaters 14.1 can be supplied with waterfrom the system. The level and/or temperature of the water can bemeasured with one or more sensors 14.4, 14.5 and can be controlled byone or more system pumps and/or drainage valves. When a desiredtemperature is reached, one or more pumps 14.3 can be configured to pumpthe water into the system without further mixing.

FIG. 18 is a block diagram depicting an embodiment of a water heatingsub-system of an amniotic bath incubator system for premature infants.As shown in FIG. 18, in some embodiments, the system comprises one ormore AC or DC water heaters with one or more heat exchangers. Inembodiments comprising more than one heat exchanger, the one or moreheat exchangers can be connected in parallel or serial line. Forexample, in some embodiments, the system can comprise two heatexchangers in a serial connection as illustrated in FIG. 18A. In certainembodiments, the system can comprise more than two heat exchangers toshorten the heat-up time.

In some embodiments, one or more valves 14.13 can be configured tosupply a fresh water tank 14.3 with water. The level and/or temperatureof the water in the tank can be controlled by one or more sensors 14.1,14.2. When the tank is filled to a required level, one or more pumps14.4 can be configured to start circulating water through a heatexchanger 14.8 via one or more valves 14.5, 14.13. When the watertemperature reaches a desired level, one or more valves 14.5 can beconfigured to break a loop and/or one or more pumps 14.4 can beconfigured to pump water into the system.

In certain embodiments, a heat exchanger primary circuit of the systemcan comprise one or more circulating pumps 14.14 configured to pumpfluid through an AC or DC heater or electric heat exchanger 14.7, andback into a collection tank 14.9. The temperature of the water in thetank can be measured before reaching the heat exchanger by one or moretemperature sensors 14.10, 14.15. Based on the detected temperature ofthe water in the tank 14.3 and/or the heat exchanger primary circuitfluid temperature, the heater 14.7 can be configured to be switched onor off.

Computer System

In some embodiments, the systems, processes, and methods describedherein are implemented using a computing system, such as the oneillustrated in FIG. 19, FIG. 19A, and/or FIG. 19B. The example computersystem 1902 is in communication with one or more computing systems 1920and/or one or more data sources 1922 via one or more networks 1918.While FIG. 19 illustrates an embodiment of a computing system 1902, itis recognized that the functionality provided for in the components andmodules of computer system 1902 may be combined into fewer componentsand modules, or further separated into additional components andmodules.

Amniotic Bath System Module

The computer system 1902 can include an Amniotic Bath Incubator System1914 that carries out the functions, methods, acts, and/or processesdescribed herein. The Amniotic Bath Incubator System 1914 can beexecuted on the computer system 1902 by a central processing unit 1910discussed further below.

In certain embodiments, as illustrated in FIGS. 19A and 19B, aProgrammable Logical Controller PLC 1952 can be an integral part of theAmniotic Bath Incubator System 1914 that carries out the functions,methods, acts, and/or processes described herein. The Amniotic BathIncubator System 1914 can be executed as a PLC program. The PLC can beconfigured to control all input and output devices as shown in FIG. 19A.The input devices 1954 shown in FIG. 19A can comprise all sensors. Theoutput devices 1956 shown in FIG. 19A can comprise valve actuators,solenoid valve actuators, solenoid actuators, heaters, and/or pumps. Insome embodiments, the Human Machine Interface or HMI 1958 can comprise atouchscreen GUI device configured to be used by a nurse or operator ofthe amniotic bath incubator system. In certain embodiments, instead ofand/or in combination with a touchscreen GUI device, one or more LED,LCD, or other displays may be used, as well as light and/or soundindicators. The memory module 1960 can be configured to store executableprograms and process data.

In some embodiments, a plurality of amniotic bath incubators can beconfigured to be controlled by a single PLC device as shown in FIG. 19B.More specifically, a plurality of amniotic bath incubators can becontrolled by a single PLC device through a Supervisory Control and DataAcquisition (SCADA) system. In certain embodiments, process data can bestored in a database. Monitoring and/or supervision can be conductedfrom a network, locally and/or from a remote position. For example, incertain embodiments, a nurse or operator can monitor multiple incubatorson single display device positioned inside the NICU unit.

In general the word “module,” as used herein, refers to logic embodiedin hardware or firmware or to a collection of software instructions,having entry and exit points. Modules are written in a program language,such as JAVA, C or C++, Ladder diagram (LD), Sequential Function Charts(SFC), Function Block Diagram (FBD), Structured Text (ST), InstructionList (IL), or the like. Software modules may be compiled or linked intoan executable program, installed in a dynamic link library, or may bewritten in an interpreted language such as BASIC, PERL, LUA, or Python.Software modules may be called from other modules or from themselves,and/or may be invoked in response to detected events or interruptions.Modules implemented in hardware include connected logic units such asgates and flip-flops, and/or may include programmable units, such asprogrammable gate arrays or processors.

Generally, the modules described herein refer to logical modules thatmay be combined with other modules or divided into sub-modules despitetheir physical organization or storage. The modules are executed by oneor more computing systems, and may be stored on or within any suitablecomputer readable medium, or implemented in-whole or in-part withinspecial designed hardware or firmware. Not all calculations, analysis,and/or optimization require the use of computer systems, though any ofthe above-described methods, calculations, processes, or analyses may befacilitated through the use of computers. Further, in some embodiments,process blocks described herein may be altered, rearranged, combined,and/or omitted.

Computing System Components

The computer system 1902 includes one or more processing units (CPU)1910, which may include a microprocessor. The computer system 1902further includes a physical memory 1912, such as random access memory(RAM) for temporary storage of information, a read only memory (ROM) forpermanent storage of information, and a mass storage device 1904, suchas a backing store, hard drive, rotating magnetic disks, solid statedisks (SSD), flash memory, phase-change memory (PCM), 3D XPoint memory,diskette, or optical media storage device. Alternatively, the massstorage device may be implemented in an array of servers. Typically, thecomponents of the computer system 1902 are connected to the computerusing a standards based bus system. The bus system can be implementedusing various protocols, such as Peripheral Component Interconnect(PCI), Micro Channel, SCSI, Industrial Standard Architecture (ISA) andExtended ISA (EISA) architectures.

The computer system 1902 includes one or more input/output (I/O) devicesand interfaces 1908, such as a keyboard, mouse, touch pad, and printer.The I/O devices and interfaces 1908 can include one or more displaydevices, such as a monitor, that allows the visual presentation of datato a user. More particularly, a display device provides for thepresentation of GUIs as application software data, and multi-mediapresentations, for example. The I/O devices and interfaces 1908 can alsoprovide a communications interface to various external devices. Thecomputer system 1902 may include one or more multi-media devices 1906,such as speakers, video cards, graphics accelerators, and microphones,for example.

Computing System Device/Operating System

The computer system 1902 may run on a variety of computing devices, suchas a server, a Windows server, a Structure Query Language server, a UnixServer, a personal computer, a laptop computer, and so forth. In otherembodiments, the computer system 1902 may run on a cluster computersystem, a mainframe computer system and/or other computing systemsuitable for controlling and/or communicating with large databases,performing high volume transaction processing, and generating reportsfrom large databases. The computing system 1902 is generally controlledand coordinated by an operating system software, such as z/OS, Windows,Linux, UNIX, BSD, SunOS, Solaris, MacOS, or other compatible operatingsystems, including proprietary operating systems. Operating systemscontrol and schedule computer processes for execution, perform memorymanagement, provide file system, networking, and I/O services, andprovide a user interface, such as a graphical user interface (GUI),among other things.

Network

The computer system 1902 illustrated in FIG. 19 is coupled to a network1918, such as a LAN, WAN, or the Internet via a communication link 1916(wired, wireless, or a combination thereof). Network 1918 communicateswith various computing devices and/or other electronic devices. Network1918 is communicating with one or more computing systems 1920 and one ormore data sources 1922. The Amniotic Bath Incubator System 1914 mayaccess or may be accessed by computing systems 1920 and/or data sources1922 through a web-enabled user access point. Connections may be adirect physical connection, a virtual connection, and other connectiontype. The web-enabled user access point may include a browser modulethat uses text, graphics, audio, video, and other media to present dataand to allow interaction with data via the network 1918.

The output module may be implemented as a combination of an all-pointsaddressable display such as a cathode ray tube (CRT), a liquid crystaldisplay (LCD), a plasma display, or other types and/or combinations ofdisplays. The output module may be implemented to communicate with inputdevices 1908 and they also include software with the appropriateinterfaces which allow a user to access data through the use of stylizedscreen elements, such as menus, windows, dialogue boxes, tool bars, andcontrols (for example, radio buttons, check boxes, sliding scales, andso forth). Furthermore, the output module may communicate with a set ofinput and output devices to receive signals from the user.

Other Systems

The computing system 1902 may include one or more internal and/orexternal data sources (for example, data sources 1922). In someembodiments, one or more of the data repositories and the data sourcesdescribed above may be implemented using a relational database, such asDB2, Sybase, Oracle, CodeBase, and Microsoft® SQL Server as well asother types of databases such as a flat-file database, an entityrelationship database, and object-oriented database, and/or arecord-based database.

The computer system 1902 also accesses one or more databases 1922. Thedatabases 1922 may be stored in a database or data repository. Thecomputer system 1902 may access the one or more databases 1922 through anetwork 1918 or may directly access the database or data repositorythrough I/O devices and interfaces 1908. The data repository storing theone or more databases 1922 may reside within the computer system 1902.

Bath Fluid Change and Rinsing

FIGS. 20A-B are portions of a single block diagram depicting one or moreembodiments of changing and/or rinsing bath fluid of an amniotic bathincubator system for premature infants.

In some embodiments, at block 101B, an operator can use a control boardto initiate a bath fluid change. For example the operator can be a nurseor other health provider. Once the operator initiates the bath fluidchange, the system can be configured to determine if all therequirements for bath change are fulfilled at block 102B. Suchrequirements can comprise, for example determining whether concentratedbath fluid cartridge is present and/or whether the wastewater tank isfull. If a concentrated bath fluid cartridge is not present, the systemcan be configured to determine that not all the requirements for a bathchange are fulfilled. Similarly, if the wastewater tank is full, thesystem may determine that not all of the requirements for a bath changeare fulfilled.

In embodiments where the system comprises an internal water treatmentunit, the system can be configured to determine whether the fresh watertank is empty and/or whether the water temperature in the tank is at arequired level. For example, if the system determines that the freshwater tank is empty and/or that the water temperature in the tank is notat the required level, the system can determine that not all therequirements for a bath change are fulfilled. In other embodiments wherethe system comprises an external water treatment unit, the system can beconfigured to determine whether the external water treatment unit isable to produce purified water and/or heating of the purified water. Forexample, if the external water treatment unit returns a positive signalthat it is able to produce purified water and/or its heating units arefunctioning correctly to allow warming of the fluid to a desiredtemperature, the system can be configured to determine that all therequirements for a bath change are fulfilled. In certain embodiments,the system can be configured to determine that all the requirements fora bath change are fulfilled when no faults are detected by one or moresystem sensors. Conversely, if at least one or more system sensorsdetect and/or provide that one or more faults exists, the system can beconfigured to determine that not all the requirements for a bath changeare fulfilled.

If the system determines that all the requirements for a bath change arefulfilled, the system can be configured to stop a heater for the bath atblock 108B. Once the bath heater stops, the bath can be flushed and thebath fluid can be drained to a wastewater tank at block 107B. After thebath fluid is drained, the system can be configured to determine whetherthe disposable bath cover should be changed at block 106B. If the systemdetermines that the bath cover does not need to be changed, the systemcan be configured to perform a cartridge check at block C1-1, which willbe discussed in more detail below.

In contrast, if the system determines that the disposable bath covershould be changed, the system can be configured to determine whetherdisinfection should be performed at block 110B. If the system determinesthat disinfection should be performed, the system can be configured toperform a disinfection process at C4. Particulars of the disinfectionprocess will be described in more detail below.

However, if the system determines that disinfection is not necessary,the system can be configured to proceed to a disposable bath coverreplacement procedure at C5. Additional details of the disposable bathcover replacement procedure will be discussed in more detail below. Ifthe system determines that the disposable bath cover replacementprocedure should be performed, an operator can use the control board tocontinue the procedure at block 111B, and thereafter perform a cartridgecheck at block C1-1.

If the system determines that not all the requirements for a bath changeare fulfilled at block 102B, an alarm can be configured to be activatedpreventing a bath change at block 103B. Despite an alarm beingactivated, the system can comprise an override function. For example, anoperator can decide whether to override the automated system by using amanual control at block 104B. If the operator determines not to overridethe automated system by using a manual control, the operator may decideto run a system diagnostics and tools at block 105B, after which isperformed the system can then again determine whether all therequirements for a bath change are fulfilled. If the operator doesdecide to override the automated system by using a manual control, theoperator may decide to initiate a safety procedure and remove thepatient or infant from the device at block 109B.

In some embodiments, the system can be configured to perform a cartridgecheck as depicted in C1-1. If the system is to perform a cartridgecheck, the system can be configured to first determine whether acartridge with concentrated bath fluid is installed in the system atblock 112B. If the system determines that a cartridge with concentratedbath fluid is not installed, the system can be configured to determinewhether a cartridge with concentrated disinfection fluid is installed atblock 113B. If the system determines that a cartridge with concentrateddisinfection fluid is not installed, the system control board can beconfigured to instruct an operator to insert a bath fluid cartridgeand/or disinfection cartridge at block 114B.

Once an operator inserts a bath fluid cartridge, the system can thenagain determine whether the cartridge with concentrated bath fluid isinstalled properly at block 112B. If the system determines that acartridge with concentrated disinfection fluid is installed, the systemcan then be configured to dispose the disinfection cartridge at blockC4-1, details of which are to be described later. In such case, once thedisinfection cartridge disposal is performed, the system can then beconfigured to again determine whether a cartridge with concentrated bathfluid is installed at block 112B.

If the system determines that a cartridge with concentrated bath fluidis installed, the system can be configured to perform a bath fluidpreparation at block C2/C3, details of which are described below. Thesystem can then be configured to determine whether the bath fluidpreparation was successful at block 120B. If the system determines thatthe bath fluid preparation was not successful, the operator may run asystem diagnostics and tools process to remove the cause of fluidpreparation failure at 125B. Based on such input from an operator, thesystem can be configured to perform diagnostics and determine whetherthe diagnostics and tools procedure was successful at block 124B. If thesystem determines that the diagnostics and tools procedure was notsuccessful, the operator can be prompted to initiate a safety procedureand remove the patient or infant from the device at block 126B. If thesystem determines that the diagnostics and tools procedure wassuccessful, the system can be configured to drain the fluid from thesystem into a wastewater tank at block 119B. Once the fluid is drainedinto the wastewater tank at block 119B the system can then be configuredto perforin a cartridge check at block C1-1 as described herein.

If the system determines that the bath fluid preparation was successfulat block 120B, the system can be configured to distribute bath fluidfrom the fluid preparation system to a manifold at block 121B. Then, insome embodiments, the system can be configured to determine whether thebath fluid temperature is suitable at block 122B. If the systemdetermines that the bath fluid temperature is suitable, for example ator near 37 C, the system can be configured to determine whether to use arinser at block 128B. If the system determines to use a rinser, thesystem can then be configured to distribute bath fluid from the manifoldto the rinser at block 127B. Once the bath fluid is distributed from themanifold to the rinser the bath fluid can then again be distributed fromthe fluid preparation system to the manifold at block 121B. If thesystem determines not to use a rinser at block 128B the system can beconfigured to distribute bath fluid into the bath without use of arinser through a laminar nozzle at block 129B.

In certain embodiments, if the system determines that the bath fluidtemperature is not suitable at block 122B, the system can be configuredto prompt an operator to run a systems and diagnostics and toolsprocedure at block 123B. The system can be configured to determinewhether the diagnostics and tools procedure was successful at block118B. If the system determines that the diagnostics and tools procedurewas not successful, the system can be configured to prompt the operatorto initiate a safety procedure. In some embodiments, the operator canthen initiate a safety procedure and remove the patient or infant fromthe device at block 109B.

If the system determines that the diagnostics and tools procedure wassuccessful at block 118B, the system can be configured to determinewhether to flush the system at 117B. If the system determines not toflush the system, the system can then be configured to determine onceagain if the bath fluid temperature is suitable at block 122B. If thesystem determines to flush the system at block 117B, fluid from thesystem is drained into a wastewater tank at block 116B. Once the fluidis drained, the operator may then use the control board to confirmwhether to retry fluid preparation at block 115B. If the operatorconfirms to retry fluid preparation, the system can then again beconfigured to perform a bath fluid preparation procedure at block C2/C3.

Bath Fluid Preparation—Internal Water Treatment System, Internal WaterSupply, and/or Internal Heater

FIG. 21 is a block diagram depicting one or more embodiments ofpreparing bath fluid of an amniotic bath incubator system for prematureinfants. More specifically, FIG. 21 depicts an embodiment in which theamniotic bath incubator system comprises an internal water treatmentsystem, an internal water supply, and/or an internal heater.

In some embodiments, an operator can initiate a bath fluid preparationprocess at block 201. Once the operator initiates a bath fluidpreparation process, the system can be configured to perform a cartridgecheck at block C1-1. Additional details about the cartridge check arediscussed above in relation to FIG. 20. Once the cartridge check isperformed, the system can be configured to open a primary pump feedlineat block 202. Once the primary pump feedline is opened, the system canbe configured to instruct the primary pump to pump fresh water throughthe water treatment system at block 203.

The system can be configured to determine whether the product watercomprises one or more acceptable characteristics. For example the systemcan be configured to determine whether the product water comprises anacceptable level of conductivity, resistivity, total dissolved solids(TDS) level, pH, or the like at block 205. If the system determines thatall necessary characteristics of the product water are not within apermitted range, the system can be configured to stop the primary pumpat block 212. In certain embodiments, the primary pump and the pump feedcan then be configured to stop at block 212.

Once the primary pump and/or pump feed is stopped, the operator may runa system diagnostics and tools procedure at block 211. The system canthen determine whether the diagnostics and tools procedure wassuccessful at block 210. If the system determines that the diagnosticsand tools procedure was not successful, the operator may initiate asafety procedure at 209. However, if the system determines that thediagnostics and tools procedure was successful at block 210, the systemcan be configured to drain the product water into the wastewater tank at204. In some embodiments, the system can then again be configured toinitiate pumping fresh water through the water treatment system byinstructing the primary pump to pump fresh water.

If the system determines that the product water comprisescharacteristics within a permitted range at block 205, the system can beconfigured to open a flow path to the heating system at block 206. Incertain embodiments, one or more sensors of the system can then measurethe water volume in the heating system storage tank at block 207. Oncethe sensor measures the water volume in the heating system storage, thesystem can be configured to determine whether the required water volumeis stored into the heating system at block 208. If the system determinesthat the required water volume is not stored into the heating system,the system can be configured to instruct the primary pump to pump freshwater through the water treatment system again at block 203.

If the system determines that the required water volume is stored in theheating system at block 208, the system can be configured to instructthe primary pump and/or pump feed to stop at block 218. In certainembodiments, one or more temperature sensors of the system can then beconfigured to measure the ambient temperature of the heated productwater at block 217. A control unit of the system, in certainembodiments, can then be configured to determine a required temperatureof the product water at block 216. Based on such calculation, theheating system can then be configured to heat the water to the requiredtemperature at block 215. Once the water reaches the requiredtemperature, the flow path to the manifold can be configured to open atblock 214. Then, the heated water can be pumped by a secondary pumpthrough a tubing at block 213.

The system can be configured to determine whether the hot water supplyhas been exhausted at block 219. Even if the system determines that thehot water supply has not been exhausted, the operator may decide to stopthe fluid preparation process at block 220. If the operator does notstop the fluid preparation process, the system can be configured tomeasure the water flow rate at block 221. In some embodiments, a controlunit of the system can then calculate the required cartridge fluidvolume for mixing based on the water flow rate at block 222. In certainembodiments, a metering pump of the system can then be configured todose the right amount of cartridge fluid into the water producing andpipe mixing at block 223. In certain embodiments, the water mixed withthe correct amount of cartridge fluid is then mixed together with theheated water at 213.

If the operator decides to stop the fluid preparation process at block220 and/or if the system determines that the hot water supply has beenexhausted at block 219, the system can be configured to close the flowpath of the product water to the manifold at block 224. In someembodiments, the pump sensors and/or heater of the system are thenturned off at block 225. In certain embodiments, one or more drainvalves of the system can then be opened at block 226, providing a flowpath to the wastewater tank. In certain embodiments, the leftover waterand bath fluid is then drained from the tubing to the wastewater tank atblock 227. Once all the leftover water and bath fluid is drained, thesystem can be configured to close the drain valves to close flow path tothe wastewater tank at block 228.

Bath Fluid Preparation—Central Water Treatment System with Heater

FIG. 22 is a block diagram depicting one or more embodiments ofpreparing bath fluid of an amniotic bath incubator system for prematureinfants. More specifically, FIG. 22 depicts an embodiment of preparingbath fluid for an amniotic bath incubator in which the incubatorcomprises a central water treatment system with a heater.

In some embodiments, an operator may initiate a bath fluid preparationprocess at block 301. After receiving instructions from an operator tobegin the bath fluid preparation process, the system can be configuredto perform a cartridge check at block C1-1, details of which arediscussed above. After performing the cartridge check, one or moretemperature sensors of the system can be configured to detect or measurethe ambient temperature of the bath fluid at block 302. In someembodiments, the control unit can be configured to calculate a requiredtemperature at block 303. In certain embodiments, the central watertreatment system can then be configured to deliver heated product waterto the device at block 304.

The system can be configured to determine whether the product watercomprises one or more acceptable characteristics at block 305. Forexample, the system can be configured to determine whether the productwater's conductivity, resistivity, and/or TDS levels are within apermitted range at block 305. If one or more monitoring sensors of thesystem determine that the product water's conductivity, resistivity,and/or TDS levels are not within the permitted range, the system can beconfigured to stop the product water inflow at block 310.

Once the product water inflow is stopped, the operator may run a systemdiagnostics and tools procedure at block 309. After the systemdiagnostics and tools procedure is performed, the system can beconfigured to determine whether the diagnostics and tools procedure wassuccessful at block 308. If the system determines that the diagnosticsand tools procedure was not successful, the system can prompt theoperator and the operator may perform a safety procedure at block 312.If the system determines that the diagnostics and tools procedure wassuccessful, the system can be configured to drain the product water intoa wastewater tank at block 307. Once the product water is drained, thesystem can be configured to return to block 302 to restart the process.

Returning to block 305, if the system determines that the product waterconductivity, resistivity, and/or TDS levels are within a permittedrange as detected by one or more monitoring sensors of the system, thesystem can be configured to determine whether the product watertemperature is suitable at block 306. If the product water temperatureis not suitable, the system can be configured to determine if theproduct water temperature is below a suitable range at block 311. If theproduct water temperature is above a suitable level, the system can beconfigured to stop the product water inflow at block 310. However if theproduct water temperature is below a suitable level, the heating systemcan be configured to heat the water to the required temperature at block313. After heating to a required temperature, a flow path to themanifold can be configured to be opened at block 317.

Similarly, if the product water temperature was determined to besuitable at block 306 the system can be configured to automatically opena flow path to the manifold at block 317. In certain embodiments, oncethe flow path to the manifold is opened, the system can be configured tomeasure the water flow rate at block 316. In certain embodiments, acontrol unit is configured to calculate a required cartridge fluidvolume for mixing based on the water flow rate at block 315.

In certain embodiments, a metering pump is configured to dose anecessary amount of cartridge fluid into the water producing and pipemixing at block 314. After the pipe mixing is performed, the system canbe configured to determine whether the required bath fluid quantity isreached at block 318. If the system determines that a required bathfluid quantity is not reached, the system can then prompt an operatorwhether the operator would like to stop the fluid preparation process at319. If the operator decides not to stop the fluid preparation process,the system can continue to measure the water flow rate at 316 andcontinue with the fluid preparation process.

However, if the operator decides to stop the fluid preparation processat 319 and/or if the system determines that the required bath fluidquantity is reached at block 318, the system can be configured to closethe flow path to the manifold at block 320. In some embodiments, oncethe flow path to the manifold is closed, a central purification watersystem can be configured to stop product water delivery at block 321.Once the product water delivery is stopped, one or more sensors and/orheating systems can be configured to be turned off at block 322. In someembodiments, the drain valves can be configured to be opened, providinga flow path to the wastewater tank at block 323. In certain embodiments,the leftover water and bath fluid is then drained from the tubing to thewastewater tank at block 324. Once all the leftover water and bath fluidis drained, the system can be configured to close the drain valves andflow path to the wastewater tank at block 325.

Disinfection

FIG. 23 is a block diagram depicting one or more embodiments ofdisinfecting an amniotic bath incubator system for premature infants.

In some embodiments, an operator can initiate a disinfection process atblock 401. Once the operator initiates a disinfection process, thecontrol board of the system can be configured to display instructions tothe operator to install a disinfection fluid cartridge at block 402. Theoperator can then install a disinfection fluid cartridge. In someembodiments, the system can then be configured to determine whether acartridge with concentrated disinfection fluid is installed at block403. If the system determines that a cartridge with concentrateddisinfection fluid is not installed, the control board display of thesystem can be configured to again instruct the operator to install adisinfection fluid cartridge at block 402.

If the system determines that a cartridge with concentrated disinfectionfluid is installed, the system can be configured to perform a systemcheck at block 404. In performing the system check, the system can beconfigured to determine whether all the requirements for disinfectionare fulfilled at block 405. If the system determines that not all of therequirements for disinfection are fulfilled, the system can prompt anoperator and the operator can decide to run a system diagnostics andtools procedure at block 410. In some embodiments, the system candetermine whether the diagnostics and tools procedure was successful atblock 409. If the system determines that the diagnostics and toolsprocedure was not successful, the operator can initiate a safetyprocedure at block 408. However if the system determines that thediagnostics and tools procedure was successful, the system can beconfigured to then again perform the system check at block 404.

If the system determines that all the requirements for disinfection arefulfilled, then the system can be configured to empty the amniotic bathby draining bath fluid into a wastewater tank of the system at block406. In some embodiments, the system can be configured to perform one ormore processes of a disposable bath cover replacement procedure. Forexample, the system can be configured to perform one or more processesof segment 1 of a disposable bath cover replacement procedure at block407.

In some embodiments, the system prompts the operator to confirm whetherthe procedure can continue at block 416, for example after completion ofone or more processes of the disposable bath cover replacementprocedure. If the operator confirms that the procedure can continue atblock 416, the system can be configured to pump product water up to themetering pump at block 415. In some embodiments, the metering pump canbe configured to dose a necessary amount of concentrated disinfectionfluid into the tube, producing in pipe mixing at block 414. In otherembodiments, the concentrated disinfection fluid is mixed with freshwater in a batch process. The mixed fluid can then be recirculated untilthe mixing is complete at block 413. Once the mixing is complete, thedisinfection fluid can be distributed through the system at block 412.The disinfection fluid can then be configured to be drained from thesystem into the wastewater tank at block 411.

After the disinfection fluid is distributed through the system and isconsequently drained from the system into the wastewater tank, thesystem control board can be configured to instruct the operator todispose the contents of the fresh water tank and also the disinfectionfluid cartridge at block 417. The operator can dispose the contents ofthe fresh water tank at block 418 and then refill the fresh water tankwith fresh water at block 419.

In some embodiments, the system can then be configured to perform adisinfection cartridge disposal by performing one or more processesdepicted within the box numbered C4-1. More specifically, the operatormay dispose the disinfection cartridge at block 420. In someembodiments, the system can then prompt the operator to confirm whetherthe procedure can continue. Once the operator confirms that theprocedure can continue after disposing the disinfection cartridge atblock 421, in some embodiments, the system can be configured to performa check to determine whether the cartridge with concentrateddisinfection fluid is still installed in the system at block 422. If thesystem determines that a disinfection cartridge is still installed inthe system, the system control board can be configured to instruct theoperator to remove the disinfection fluid cartridge at block 423. Insome embodiments, the control board can refer to a digital touchscreendisplay and/or physical button control board. The operator may thendispose the disinfection cartridge at block 420.

If the system determines that a cartridge with concentrated disinfectionfluid is no longer installed at block 422, the system can be configuredto pump product water through the system at block 430. In someembodiments, water from the system can be drained into the wastewatertank at block 429. In certain embodiments, the system control board canbe configured to instruct the operator to install a concentrated bathfluid cartridge at block 428. The operator may install a concentratedbath fluid cartridge at block 427.

In some embodiments, the system can be configured to perform a check todetermine whether a cartridge with concentrated bath fluid was installedat block 426. If the system determines that a cartridge withconcentrated bath fluid is not installed, the system control board canagain be configured to instruct the operator to install a concentratedbath fluid cartridge at block 428. However, if the system determinesthat a cartridge with concentrated bath fluid is installed, the systemcan be configured to perform one or more processes of segment 2 of thedisposable bath cover replacement procedure at block 424. Afterperforming one or more processes of segment two of the disposable bathcover replacement procedure, the operator may confirm that the procedureis completed at block 425.

Disposable Bath Cover Replacement Procedure

FIG. 24 is a block diagram depicting one or more embodiments ofreplacing a bath cover of an amniotic bath incubator system forpremature infants. In some embodiments, a disposable bath coverreplacement procedure can comprise of one or more processes, which canbe categorized into two segments denoted as segments 1 and 2 herein.

In some embodiments, an operator may use the control board of the systemto confirm start of a disposable bath replacement procedure at block501. The operator may then safely detach one or more medical devicesand/or sensors from the patient or infant at block 502. The operator mayalso unlock a safety harness attached to the patient or infant at block503. Once the safety harness and/or one more medical devices or sensorsare all removed from the patient or infant, the operator may safelyremove the patient or infant from the device at block 504.

In some embodiments, once the patient or infant is safely removed, theoperator may move a level control mechanism to lower the position of thesystem at block 505. For example, the level control mechanism can beautomatic or manual. The level control mechanism can be configured tolower the position of the system for easy removal of the bath coverafter unlocking the mechanism by the operator.

In some embodiments, the operator may detach an inflow hose from thesystem at block 506. The operator may lift the disposable bath coververtically, horizontally, and/or diagonally to detach from thewastewater connection at block 511. In some embodiments, the operatormay move the disposable cover horizontally, vertically, and/ordiagonally toward or from him or herself to remove the disposable coverfrom the device at block 510. The operator may then dispose the usedbath cover at block 509.

The system can be configured to determine whether the bath coverreplacement procedure is being performed as part of a disinfectionprocedure at block 508. If the bath cover replacement procedure is beingperformed as part of a disinfection procedure, the operator may use thecontrol board to confirm to the system that segment 1 of the disposablebath cover replacement procedure is completed at block 507. Theprocesses described in blocks 501 through 511 can be categorized asbeing part of segment 1 of the disposable bath cover replacementprocedure.

If the operator uses the control board to confirm that segment 1 iscomplete as depicted in block 507 and/or if the bath cover replacementprocedure was not performed as part of disinfection procedure asdetermined in block 508, the operator may bring a new sterile disposablebath cover at block 512, beginning segment 2 of the disposable bathcover replacement procedure. In order to attach the new steriledisposable bath cover, the operator may move the disposable coverhorizontally, vertically, and/or diagonally to position the disposablecover over the placeholders at block 513. The operator may then lay downthe disposable bath cover vertically, horizontally, and/or diagonally toposition the disposable bath cover on placeholders at block 514. Theoperator may then push down the bottom center and/or rim or one or moreother portions of the bath cover to firmly attach the wastewater lineconnection to the disposable cover at block 515. The operator may alsoattach an inflow hose to the system at block 516.

Once the inflow hose, wastewater line connection, and/or disposable bathcover is attached to the system, the operator may move a level controlmechanism of the system at block 522. For example, the operator mayutilize a manual and/or automatic level control mechanism of the systemto, its highest position to lock the mechanism to the bath cover atblock 522.

In some embodiments, the operator may then move in the patient or infantinto the device at block 521. Once the patient or infant is positionedwithin the amniotic bath, the operator may lock the patient or infantinto the safety harness at block 520 in order to ensure that the infantis not accidentally submerged in the amniotic fluid. The operator mayalso, in some embodiments, position one or more tubes and catheters ontoanchor points on one or more bridges above the bath at block 519. Theoperator may, in some embodiments, safely attach one or more medicaldevices and/or sensors, such as one or more tubes or catheters, to thepatient or infant at block 518. In certain embodiments, the operator mayuse the control board to confirm that segment 2 of the disposable bathcover replacement procedure is completed at block 517.

Wastewater Tank Discharge

FIGS. 25A-B are block diagrams depicting one or more embodiments ofdischarging a wastewater tank of an amniotic bath incubator system forpremature infants. In some embodiments, an operator can use a controlboard to initiate the wastewater tank discharge procedure at block 601.In certain embodiments, even without operator initiation, the system canbe configured to determine whether a predefined wastewater level hasbeen reached in the wastewater tank and initiate the wastewater tankdischarge procedure automatically at block 602.

Once the wastewater tank discharge process has been initiated, thesystem can be configured to determine whether the system or device isconnected to a sewage system at block 603. If the system or device isconnected to a sewage system, the system can be configured to determinewhether the sewer line is flooded at block 604. If the sewer line is notflooded, the system can be configured to open the wastewater dischargeline at block 607. In some embodiments, a system control unit is thenconfigured to start one or more pumps for the discharge process at block610. In some embodiments, the one or more pumps then discharge thewastewater tank contents into the sewer at block 611.

In some embodiments, the system can be configured to determine whether alower level sensor within the wastewater tank is reached at a definedtimeframe at block 612. If the system determines that the tank lowerlevel sensor is reached at a defined timeframe, the system control unitcan be configured to stop the one or more pumps at block 608. Once theone or more pumps are stopped, the wastewater discharge line can beconfigured to be opened at block 609, triggering an alarm at block 605.Once the alarm is triggered at block 605, in some embodiments, thesystem can be configured to prompt an operator and an operator mayinitiate a safety procedure at block 606.

If the system determines that a tank lower level sensor is reached at adefined timeframe at block 612, the system control unit can beconfigured to stop one or more pumps at block 613. In some embodiments,the wastewater discharge line can be closed at block 614. In certainembodiments, the system control board can be configured to notify theoperator that the wastewater tank discharge procedure is completed atblock 615.

If the system determines that the system or device is not connected to asewage system at block 603, the system control unit can be configured tostop power supply to the wastewater subsystem at block 616. In certainembodiments, the system control board can be configured to notify theoperator to continue the procedure at block 617. The operator mayapproach the device or system from a front, side, or backside and pullthe wastewater subsystem out of its slot in the assembly at block 618.The operator may detach a cable connection to the wastewater subsystemat block 619. The operator may also detach a wastewater tube connectionat block 620.

The operator may take or roll the wastewater subsystem to a wastewaterdisposal suite at block 625. The operator may connect an outlet hosefitting of the wastewater subsystem to the wastewater disposal sewerfitting at block 624. In some embodiments, the wastewater subsystem cancomprise a powered control unit. As such, in some embodiments, theoperator may switch on an autonomous battery powered control unit on thewastewater subsystem at block 623. The operator may use the controlboard to initiate wastewater disposal at block 622.

Upon instruction from the operator, the wastewater subsystem controlunit may be configured to power and/or start one or more pumps fordischarge of the wastewater subsystem at block 621. The pump may beconfigured to discharge wastewater tank content into the sewer at block626. The system in some embodiments can be configured to determinewhether the tank lower level sensor is reached at a defined timeframe atblock 627. If the system determines that the tank lower level sensor isnot reached at the defined timeframe, the wastewater subsystem controlunit can be configured to stop the one or more for discharge at block632. The system can then be configured to sound one or more alarmsnotifying an operator of the discharge failure at block 633. Theoperator may initiate a safety procedure at block 634.

However, if the tank lower level sensor is reached after a definedtimeframe, the wastewater subsystem control unit can be configured tostop the one or more pumps for discharge at block 628. The system insome embodiments can be configured to sound one or more alarms notifyingthe operator that the discharge process has been completed at block 629.Subsequently and/or at the same time, the wastewater subsystem controlunit can be configured to stop the operation of the one or more pumps atblock 630. In some embodiments, the system can be configured to soundone or more alarms notifying the operator that the discharge has beencompleted at block 631.

The operator may use the control board to switch off the wastewaterdischarge subsystem at block 641 in some embodiments. The operator maydisconnect the outlet hose fitting of the wastewater subsystem from thewastewater disposal sewage fitting at block 640. The operator may thentake or roll the wastewater subsystem back to the incubator at block639. The operator may then attach the wastewater tube connection of thesystem or incubator to the wastewater subsystem at block 638. Theoperator may also attach a cable connection of the system to thewastewater subsystem at block 637. The operator may insert thewastewater subsystem into its slot in the incubator or device or systemat block 635. The operator may confirm, in some embodiments, that thewastewater tank discharge process has been completed at block 636.

Fresh Water Tank Replacement and/or Fill Process

FIGS. 26A-B are block diagrams depicting one or more embodiments ofreplacing and/or filling a fresh water tank of an amniotic bathincubator system for premature infants. In some embodiments, an operatormay use a control board of the system to initiate the fresh water tankreplacement and fill process at block 701. In certain embodiments, evenwithout instruction from an operator, the system can be configured toautomatically initiate a fresh water tank replacement and fill processupon determining that the fresh water tank is empty at block 702. Insome embodiments, the system can be configured to initiate a fresh watertank replacement and fill process according to a scheduled disposaltime. As such, in some embodiments, when a scheduled disposal time isreached, the fresh water tank replacement and fill process can beautomatically initiated at block 703.

Once the fresh water tank replacement and fill process has beeninitiated, the system control unit can be configured to turn off thepower supply of the fluid preparation subsystem at block 704. In certainembodiments, the system control board can be configured to notify theoperator to continue the procedure at block 705. The operator mayapproach the device or system from the front, side, or back and pull thefluid preparation subsystem out of its slot in the device at block 706.The operator may detach one or more cable connections connecting thefluid preparation subsystem with the amniotic bath incubator at block707. The operator may also detach one or more tube connectionsconnecting the fluid preparation subsystem and the amniotic bathincubator at block 708.

The system can be configured to determine whether to dispose the usedfresh water tank and/or contents thereof at block 712. If the systemdetermines to dispose the used fresh water tank and/or its contents atblock 712, the operator may remove the fresh water tank from its slot inthe subsystem at block 711. The operator may dispose the used freshwater tank and/or its contents at block 710. The operator may theninsert a new disposable fresh water tank in its slot in the subsystem atblock 709. If the system determines not to dispose the fresh water tankat block 712, the system can be configured to determine whether theamniotic bath incubator or device or system is connected to water supplysystem at block 719.

If the device or system is connected to a water supply system, anoperator may connect the fresh water tank to an inflow line at block718. The operator may also attach one or more tube connectionsconnecting the fresh water tank to the amniotic bath incubator at block717. The operator may also attach one or more cable connections to thefresh water tank at block 716. The operator may also insert a fluidpreparation subsystem into its slot in the device at block 715. In someembodiments, the operator may also use the control board to initiatefilling of the fresh water tank at block 714.

Upon initiation of the fresh water tank fill by the operator, the systemcan be configured to open a water intake valve at block 713. After thefresh water tank is filled with fresh water, a sensor of the fresh watertank can be configured to determine whether the fresh water tank toplevel has been reached at block 720. If the fresh water tank top levelsensor has been reached, the water intake valve can be configured toclose at block 721. Once the water intake valve has been closed, thesystem control board can be configured to notify the operator that theprocedure has been completed at block 722.

If the device is not connected to a water supply system as determined atblock 719, the operator may take or roll the fluid preparation subsystemto a fresh water supply or a faucet at block 726. The operator mayconnect a fresh water tank inflow hose fitting of the fluid preparationsubsystem to the faucet at block 725. In some embodiments, the fluidpreparation subsystem comprises a powered control unit. As such, in someembodiments, the operator may switch on an autonomous battery poweredcontrol unit on the fluid preparation subsystem at block 724. Theoperator may use the control board to initiate tank fill at block 723.

In some embodiments, the operator may open a faucet valve at block 727.In certain embodiments, a fresh water tank top level sensor can beconfigured to determine whether the tank is full or not at block 728. Ifthe fresh water tank top level sensor determines that the tank is full,the sensor can be configured to trigger an alarm that the tank is fullat block 728. Once the alarm is triggered, the operator may be promptedto close the faucet valve at block 729. If the operator does not closethe faucet valve, an overflow line can be configured to drain excesswater out of the flow preparation system at block 731, returning theprocess back to block 728.

If the operator closes the faucet valve at block 729, the operator mayuse a control board to switch off the fluid preparation subsystem atblock 730. The operator may disconnect the freshwater tank inflow hosefitting from the faucet at block 732. The operator may take the fluidpreparation subsystem back to the incubator at block 733. In someembodiments, the operator may attach one or more tube connections to thefluid preparation subsystem at block 734. The operator may also attachone or more cable connections to the fluid preparation subsystem atblock 735. The operator may then insert and lock the fluid preparationsubsystem into its slot and the amniotic bath incubator at block 736.

In certain embodiments, the operator may use a control board to confirmthat the fresh water tank replacement and fill process has beencompleted at block 737. In some embodiments, the system can then beconfigured to determine whether the conductivity, resistivity, and/orTDS monitoring sensors show that one or more characteristics of thefluid and the fluid preparation subsystem is within a predeterminedrange at block 738. If the system determines that the one or morecharacteristics of the fluid and the fluid preparation subsystem arewithin a predetermined range, the system control board can be configuredto notify the operator that the procedure has been completed at block739.

In some embodiments, if one or more characteristics of the fluid and thefluid preparation subsystem are not within a permitted range, the wateror fluid path through the system can be configured to be automaticallyclosed at block 740. In certain embodiments, an alarm can be configuredto be triggered and notify an operator about contamination of the watersystem at block 741. In some embodiments, the operator can then initiatea safety procedure at block 742.

Although this invention has been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that the invention extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinvention and obvious modifications and equivalents thereof. Inaddition, while several variations of the embodiments of the inventionhave been shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. It should be understood that various featuresand aspects of the disclosed embodiments can be combined with, orsubstituted for, one another in order to form varying modes of theembodiments of the disclosed invention. Any methods disclosed hereinneed not be performed in the order recited. Thus, it is intended thatthe scope of the invention herein disclosed should not be limited by theparticular embodiments described above.

Conditional language, such as, among others, “can,” “could,” “might,” or“may,” unless specifically stated otherwise, or otherwise understoodwithin the context as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements and/or steps areincluded or are to be performed in any particular embodiment. Theheadings used herein are for the convenience of the reader only and arenot meant to limit the scope of the inventions or claims.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” and the like includesthe number recited and also represent an amount close to the statedamount that still performs a desired function or achieves a desiredresult. For example, the terms “approximately”, “about”, and“substantially” may refer to an amount that is within less than 10% of,within less than 5% of, within less than 1% of, within less than 0.1%of, and within less than 0.01% of the stated amount. Numbers preceded bya term such as “about” or “approximately” include the recited numbers.For example, “about 3 mm” includes “3 mm.”

The headings provided herein, if any, are for convenience only and donot necessarily affect the scope or meaning of the devices and methodsdisclosed herein.

What is claimed is:
 1. A neonatal incubator for an infant, the neonatalincubator comprising: an amniotic bath comprising synthetic amnioticfluid, wherein the synthetic amniotic fluid comprises one or moreelectrolytes and one or more minerals, wherein the synthetic amnioticfluid is produced by: installing a cartridge in the neonatal incubator,wherein the cartridge comprises the one or more electrolytes and the oneor more minerals; and dissolving contents of the cartridge in purifiedwater; a purified water supply tank configured to provide the purifiedwater for dissolving contents of the cartridge; a waste water removaltank configured to remove waste water from the amniotic bath; and a bathcover selectively attachable to the amniotic bath, wherein the bathcover is sterile and disposable, and wherein the bath cover comprises asafety harness configured to maintain a position of the infant insidethe amniotic bath such that a head of the infant is not submerged in theamniotic bath.
 2. The neonatal incubator of claim 1, further comprising:a temperature sensor configured to detect a temperature of the syntheticamniotic fluid; and a heater configured to heat the synthetic amnioticfluid when the detected temperature is below a predetermined thresholdvalue.
 3. The neonatal incubator of claim 1, wherein the purified watersupply tank and the waste water removal tank are selectively removablefrom the neonatal incubator.
 4. The neonatal incubator of claim 1,wherein the synthetic amniotic fluid further comprises albumin.
 5. Theneonatal incubator of claim 1, wherein the cartridge further comprisesglucose and one or more amino acids.
 6. The neonatal incubator of claim1, wherein the cartridge further comprises one or more therapeuticagents configured to be absorbed by the infant.
 7. The neonatalincubator of claim 1, wherein the synthetic amniotic fluid comprises apH level between a range of about 7.5 and about 9.0.
 8. The neonatalincubator of claim 1, wherein a pH level and osmolality of the syntheticamniotic fluid is modified according to growth of the infant.
 9. Theneonatal incubator of claim 1, further comprising a synthetic amnioticfluid disposal unit configured to facilitate disposal of stool and thesynthetic amniotic fluid to the waste water tank, wherein the syntheticamniotic fluid disposal unit further comprises a stool collector, a bathfluid inflow portion, one or more filters, and a plug unit.
 10. Theneonatal incubator of claim 1, further comprising an adapter seatconfigured to be coupled to the bath cover, wherein the adapter seatcomprises the adapter seat is selected from a plurality of adapterseats, wherein each of the plurality of adapter seats comprisesdifferent sizes.
 11. The neonatal incubator of claim 1, wherein thesynthetic amniotic fluid is provided to the bath through a divergentnozzle.
 12. The neonatal incubator of claim 1, further comprising afluid sensor configured to be worn proximate a neck of the infant,wherein the fluid sensor is configured to detect presence of fluid incontact with the fluid sensor, wherein detection of presence of fluid incontact with the fluid sensor causes at least a portion of the syntheticamniotic fluid to be automatically removed from the amniotic baththrough the waste water removal system.
 13. The neonatal incubator ofclaim 1, further comprising one or more bridges placed over the bathcover.
 14. The neonatal incubator of claim 13, wherein the one orbridges are configured to anchor a first end of one or more of a feedingtube, an oxygen tube, and an umbilical catheter over the syntheticamniotic fluid.
 15. The neonatal incubator of claim 14, wherein a secondend of one or more of the feeding tube, the oxygen tube, and theumbilical catheter is connected to the infant.
 16. A neonatal incubatorfor an infant, the neonatal incubator comprising: an amniotic bathcomprising synthetic amniotic fluid, wherein the synthetic amnioticfluid comprises one or more electrolytes and one or more minerals,wherein the synthetic amniotic fluid is produced by: installing acartridge in the neonatal incubator, wherein the cartridge comprises theone or more electrolytes and the one or more minerals; and dissolvingcontents of the first cartridge in purified water; a purified watersupply tank configured to provide the purified water for dissolvingcontents of the first cartridge; a waste water removal tank configuredto remove waste water from the amniotic bath; and a bath coverselectively attachable to the amniotic bath, wherein the bath cover issterile and disposable, wherein the bath cover comprises a safetyharness configured to maintain a position of the infant inside theamniotic bath such that a head of the infant is not submerged in theamniotic bath, and wherein two peripheral sides of the bath cover areconnected by a bridge over the bath, wherein the bridge comprises ananchoring mechanism for anchoring one end of an umbilical catheter overthe synthetic amniotic fluid.
 17. The neonatal incubator of claim 16further comprising a fluid sensor configured to be worn around a neck ofthe infant, wherein the fluid sensor is configured to detect presence offluid in contact with the fluid sensor, wherein detection of presence offluid in contact with the fluid sensor causes at least a portion of thesynthetic amniotic fluid to be automatically removed from the amnioticbath through the waste water removal system.
 18. The neonatal incubatorof claim 16, wherein the bridge is configured to further anchor a firstend of a feeding tube over the synthetic amniotic fluid.
 19. Theneonatal incubator of claim 16, wherein a second end of the umbilicalcatheter is connected to the infant.
 20. The neonatal incubator of claim16, wherein the synthetic amniotic fluid further comprises one or moremedicines configured to be absorbed by the infant, and wherein thecartridge further comprises the one or more medicines.
 21. A method ofincubating an infant, wherein the method comprises: providing a neonatalincubator for the infant, wherein the neonatal incubator comprises anamniotic bath; providing purified water to the amniotic bath; dissolvingcontents of a cartridge in the purified water to obtain a syntheticamniotic fluid, wherein the contents of the cartridge comprise one ormore electrolytes and one or more minerals; placing a selectivelyattachable bath cover over the amniotic bath, wherein the bath cover issterile and disposable; placing the infant in the amniotic bath andattaching the infant to a safety harness of the bath cover, wherein thesafety harness maintains a position of the infant inside the amnioticbath such that a head of the infant is not submerged in the syntheticamniotic fluid; attaching a first end of an umbilical catheter to aportion of the infant submerged in the synthetic amniotic fluid andattaching a second end of the umbilical catheter to a bridge over thebath, wherein the bridge is configured to connect two peripheral sidesof the bath cover over the bath; and periodically removing waste waterfrom the amniotic bath.
 22. The method of claim 21, further comprising:detecting a temperature of the synthetic amniotic fluid; and heating thesynthetic amniotic fluid when the detected temperature is below apredetermined threshold value.
 23. The method of claim 21, whereinpurified water is provided to the amniotic bath by removing a modularpurified water tank from the neonatal incubator, adding purified waterto the modular purified water tank, and reattaching the modular purifiedwater tank to the neonatal incubator.
 24. The method of claim 21,wherein the waste water is removed from the amniotic bath by collectingwaste water from the amniotic bath in a modular waste water tank of theneonatal incubator, removing the modular waste water tank, emptying thewaste water from the modular waste water tank, and reattaching themodular waste water tank to the neonatal incubator.
 25. The method ofclaim 21, further comprising dissolving albumin in the syntheticamniotic fluid.
 26. The method of claim 21, further comprisingdissolving glucose and one or more amino acids in the synthetic amnioticfluid.
 27. The method of claim 21, further comprising administering oneor more medicines to the infant by dissolving the one or more medicinesin the synthetic amniotic fluid.
 28. The method of claim 21, furthercomprising attaching a necklace around a neck of the infant, wherein thenecklace comprises a fluid sensor, wherein the fluid sensor isconfigured to detect presence of fluid in contact with the fluid sensor.29. The method of claim 28, further comprising automatically removing atleast a portion of the synthetic amniotic fluid from the amniotic bathwhen the fluid sensor detects presence of fluid in contact with thefluid sensor.
 30. The method of claim 21, further comprising attaching afirst end of a feeding tube to the infant and attaching a second end ofthe feeding tube to the bridge.